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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR LYRICA

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505(b)(2) Clinical Trials for Lyrica

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01638273 PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects Completed GL Pharm Tech Corporation Phase 1 2014-02-01 The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation NCT02326987 A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects Completed GL Pharm Tech Corporation Phase 1 2013-10-01 The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation NCT02327000 A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers Completed GL Pharm Tech Corporation Phase 1 2014-10-01 The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lyrica

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00280059 Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy Completed Pfizer Phase 3 2006-08-01 The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
NCT00288639 Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER). Completed Pfizer Phase 4 2005-12-01 The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
NCT00291148 Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain Completed University of Manitoba Phase 3 2006-03-01 This is a comparative drug trial involving patients with clinically definite Multiple Sclerosis and documented neuropathic pain. Patients will be randomized to receive treatment with either paroxetine or pregabalin. After dose titration, participants will complete various pain scale assessments at several points during the study in order to determine the effectiveness of their assigned pain medication.
NCT00351611 Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo Recruiting Pfizer Phase 4 2006-07-01 Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lyrica

Condition Name

Condition Name for Lyrica
Intervention Trials
Healthy 9
Epilepsy 5
Neuropathic Pain 5
Fibromyalgia 5
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Condition MeSH

Condition MeSH for Lyrica
Intervention Trials
Neuralgia 17
Diabetic Neuropathies 8
Pain, Postoperative 8
Peripheral Nervous System Diseases 7
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Clinical Trial Locations for Lyrica

Trials by Country

Trials by Country for Lyrica
Location Trials
United States 306
India 24
Canada 21
China 16
Korea, Republic of 10
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Trials by US State

Trials by US State for Lyrica
Location Trials
Florida 16
Texas 15
California 14
North Carolina 13
Georgia 12
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Clinical Trial Progress for Lyrica

Clinical Trial Phase

Clinical Trial Phase for Lyrica
Clinical Trial Phase Trials
Phase 4 23
Phase 3 24
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Lyrica
Clinical Trial Phase Trials
Completed 47
Recruiting 10
Not yet recruiting 8
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Clinical Trial Sponsors for Lyrica

Sponsor Name

Sponsor Name for Lyrica
Sponsor Trials
Pfizer 36
GL Pharm Tech Corporation 4
McMaster University 2
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Sponsor Type

Sponsor Type for Lyrica
Sponsor Trials
Industry 55
Other 49
NIH 2
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