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Profile for Tradename: METFORMIN HYDROCHLORIDE

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Metformin Hydrochloride is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Cspc Ouyi Pharm Co, Impax Labs, Inventia Hlthcare, Ivax Sub Teva Pharms, Lupin Ltd, Mutual Pharm, Mylan, Mylan Pharms Inc, Nostrum Pharms Llc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Teva, Torrent Pharm, Torrent Pharms Ltd, Watson Labs Inc, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Indicus Pharma, Ipca Labs Ltd, Marksans Pharma, Mutual Pharma, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Torrent Pharms, Watson Labs, Watson Labs Florida, and Zydus Hlthcare. and is included in sixty-four NDAs.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are fourty-six drug master file entries for this compound. Eight suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for Tradename: METFORMIN HYDROCHLORIDE

Patents:0
Applicants:41
NDAs:64

Clinical Trials for: METFORMIN HYDROCHLORIDE

Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets
Status: Withdrawn Condition: Diabetes Mellitus Type 2

Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Status: Completed Condition: Type 2 Diabetes Mellitus

Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Status: Completed Condition: Healthy

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Metformin; Healthy Subjects

Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Status: Completed Condition: Type 2 Diabetes Mellitus

Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
Status: Completed Condition: Healthy

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
Status: Completed Condition: Diabetes Mellitus

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
Status: Completed Condition: Diabetes Mellitus

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers
Status: Terminated Condition: Diabetes Mellitus, Type 2

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
Status: Completed Condition: Type 2 Diabetes Mellitus

Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Status: Completed Condition: Type 2 Diabetes Mellitus

A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
Status: Completed Condition: Healthy Volunteers

Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet
Status: Completed Condition: Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose

Study of Metformin With Simvastatin for Men With Prostate Carcinoma
Status: Recruiting Condition: Prostate Carcinoma

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
Status: Completed Condition: Type 2 Diabetes Mellitus

Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium
Status: Completed Condition: Diabetes Mellitus

Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Status: Recruiting Condition: Obesity; Weight Gain; Psychotropic Induced Weight Gain

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 20mg
Status: Completed Condition: Diabetes Mellitus

An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
Status: Terminated Condition: Diabetes Mellitus, Type 2

Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Status: Completed Condition: Diabetes Mellitus; Lactic Acidosis

Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects
Status: Completed Condition: Type 2 Diabetes Mellitus

A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
Status: Completed Condition: Type 2 Diabetes

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
Status: Completed Condition: Healthy

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
Status: Completed Condition: Healthy

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg
Status: Completed Condition: Diabetes Mellitus

BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Status: Withdrawn Condition: Type 2 Diabetes

Stereotactic Radiosurgery and Metformin Hydrochloride in Treating Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer
Status: Not yet recruiting Condition: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage I-III Pancreatic Cancer

Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer
Status: Recruiting Condition: Breast Cancer; Obesity

Metformin in Non Small Cell Lung Cancer (NSCLC)
Status: Not yet recruiting Condition: Lung Cancer

Metformin for the Treatment of Endometrial Hyperplasia
Status: Recruiting Condition: Endometrial Hyperplasia; Endometrial Hyperplasia Without Atypia

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Status: Active, not recruiting Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg
Status: Completed Condition: Diabetes Mellitus

Evaluating of Pharmacokinetic Profile of BCWP_C001 and Co-administration of Rosuvastatin and Metformin
Status: Not yet recruiting Condition: Healthy

Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM
Status: Completed Condition: Diabetes

Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Spironolactone Plus Metformin in Polycystic Ovary Syndrome
Status: Completed Condition: Polycystic Ovary Syndrome

Drug-Drug Interaction Study With Metformin and Nizatidine
Status: Completed Condition: Healthy

Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer
Status: Not yet recruiting Condition: Atypical Ductal Breast Hyperplasia; BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Status: Completed Condition: Type 2 Diabetes Mellitus

The Metformin-FMD Trial
Status: Completed Condition: Ischemia Reperfusion Injury; Endothelial Function

Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
Status: Terminated Condition: Colon Cancer

A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
Status: Completed Condition: Healthy Participants

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients
Status: Active, not recruiting Condition: Obesity

Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
Status: Completed Condition: Obesity

Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
Status: Completed Condition: Healthy

A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic Cancer
Status: Recruiting Condition: Metastatic Pancreatic Adenocarcinoma

Bioequivalence Study for Acarbose / Metformin FDC
Status: Completed Condition: Diabetes Mellitus, Type II

Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
Status: Active, not recruiting Condition: Colorectal Neoplasms

Metformin-Dipyridamole Interaction Trial
Status: Completed Condition: Diabetes

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg
Status: Completed Condition: Type 2 Diabetes Mellitus

Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery
Status: Recruiting Condition: Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer

Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
Status: Completed Condition: Healthy

Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin
Status: Active, not recruiting Condition: Healthy

PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
Status: Recruiting Condition: Diabetes Mellitus, Non-Insulin-Dependent; Hypertriglyceridemia

Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
Status: Recruiting Condition: Type 2 Diabetes Mellitus

A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Non-fasting Conditions
Status: Completed Condition: Healthy

Organic Cation Transporter 1 (OCT1), on Response to Metformin in Healthy Subjects
Status: Completed Condition: Other Conditions That May Be A Focus of Clinical Attention

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Status: Completed Condition: Diabetes Mellitus, Type 2

Metformin in Stage IV Lung Adenocarcinoma
Status: Recruiting Condition: Non-small Cell Lung Cancer

A Trial of Metformin for Colorectal Cancer Risk Reduction Among Patients With a History of Colorectal Adenomas and Elevated Body Mass Index
Status: Completed Condition: Adenomatous Polyp; Colorectal Cancer; Obesity

Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Status: Recruiting Condition: Polycystic Ovary Syndrome

Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
Status: Completed Condition: Healthy

Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers
Status: Completed Condition: Healthy

Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
Status: Recruiting Condition: Breast Cancer Prevention

Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
Status: Recruiting Condition: Hormone Receptor Positive Malignant Neoplasm of Breast

Lapatinib With Sirolimus or Metformin
Status: Active, not recruiting Condition: Advanced Cancers

Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes (CONSENT)
Status: Not yet recruiting Condition: Diabetes Mellitus, Type 2

Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia
Status: Recruiting Condition: Abortion, Habitual

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

Metformin Hydrochloride and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Status: Not yet recruiting Condition: Brenner Tumor; Malignant Ascites; Malignant Pleural Effusion; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Primary Peritoneal Cavity Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Ovarian Germ Cell Tumor; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Ovarian Germ Cell Tumor; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Ovarian Germ Cell Tumor; Stage IIIC Primary Peritoneal Cavity Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IV Primary Peritoneal Cavity Cancer

Metformin for the Treatment of Unexplained Hypospermatogenesis
Status: Recruiting Condition: Infertility

Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
Status: Completed Condition: Type 2 Diabetes Mellitus

Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
Status: Completed Condition: Rheumatoid Arthritis

Effect of Metformin on Breast Cancer Metabolism
Status: Completed Condition: Breast Cancer

Metformin in Obese Children and Adolescents
Status: Recruiting Condition: Obesity; Insulin Resistance

Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
Status: Recruiting Condition: Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Bronchoalveolar Cell Lung Cancer; Large Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

PCOS Treatment Using DLBS3233, Metformin, and Combination of Both
Status: Recruiting Condition: Polycystic Ovary Syndrome (PCOS); Insulin Resistance

Bioequivalence of a Medium, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects.
Status: Completed Condition: Healthy

Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
Status: Completed Condition: Healthy

Metformin and Sitagliptin Therapy for Adult Patients With Type 2 Diabetes Admitted to the General Medical Unit
Status: Not yet recruiting Condition: Type 2 Diabetes Mellitus

Metformin Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Status: Not yet recruiting Condition: Ovarian Papillary Serous Carcinoma; Ovarian Serous Cystadenocarcinoma; Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Primary Peritoneal Cavity Cancer

The Metformin Active Surveillance Trial (MAST) Study
Status: Recruiting Condition: Prostate Cancer

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants
Status: Completed Condition: Healthy

Exercise and Metformin in Colorectal and Breast Cancer Survivors
Status: Recruiting Condition: Colorectal Cancer; Breast Cancer

Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes
Status: Active, not recruiting Condition: Type 2 Diabetes

Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Status: Completed Condition: PCOS; Obesity

Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
Status: Completed Condition: Type 2 Diabetes Mellitus

Metformin in Amnestic Mild Cognitive Impairment
Status: Completed Condition: Amnestic Mild Cognitive Impairment

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
Status: Recruiting Condition: Endometrial Adenocarcinoma; Endometrial Clear Cell Carcinoma; Endometrial Papillary Serous Carcinoma; Recurrent Endometrial Carcinoma; Stage IIIA Endometrial Carcinoma; Stage IIIB Endometrial Carcinoma; Stage IIIC Endometrial Carcinoma; Stage IVA Endometrial Carcinoma; Stage IVB Endometrial Carcinoma

Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
Status: Completed Condition: Metabolic Complications

Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes
Status: Not yet recruiting Condition: Type 2 Diabetes

Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
Status: Completed Condition: Coronary Artery Disease

A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib
Status: Completed Condition: Healthy

Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Status: Active, not recruiting Condition: Fatty Liver

Metformin Hydrochloride as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Drug-drug Interaction Study With Metformin and Imatinib
Status: Completed Condition: Healthy

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy in Stage IV NS-NSCLC
Status: Recruiting Condition: Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Metastatic; Nonsquamous Nonsmall Cell Neoplasm of Lung

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Indicus Pharma
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL079148Nov 25, 2008RXNo<disabled><disabled>
Watson Labs Florida
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL075961Jan 25, 2002RXNo<disabled><disabled>
Mylan
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL076650Sep 13, 2005RXNo<disabled><disabled>
Amneal Pharms Ny
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL077880Jun 5, 2006RXNo<disabled><disabled>
Apotex
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL090666Dec 7, 2011RXNo<disabled><disabled>
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