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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

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Clinical Trials for Diphenhydramine Hydrochloride; Naproxen Sodium

Trial ID Title Status Sponsor Phase Summary
NCT01118273 Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine Completed Bayer Phase 4 The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
NCT01280591 Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain Completed Bayer Phase 3 The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.
NCT01365052 Safety Trial of Naproxen Sodium/ Diphenhydramine Completed Bayer Phase 3 The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
NCT01495858 Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain Completed Bayer Phase 3 The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.
NCT01666678 Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Completed Bayer Phase 1 The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x AleveĀ® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
NCT03299452 Clinical Studies by Using Accelerated PDX Model to Screen Drugs for Advanced Solid Tumor Recruiting Haining Health-Coming Biotech Co., Ltd. Phase 2 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS,safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on the accelerated PDX model screening in subjects with advanced malignant tumor.
NCT03424135 A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions Completed Bayer Phase 1 To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets (Reference) after a single oral administration (2 x naproxen sodium 220 mg and DPH HCl 25 mg combination product) under fed conditions in healthy adult subjects. To assess the safety and tolerability of the investigational products in terms of adverse events (AEs) and clinical parameters (systolic/diastolic blood pressure, pulse rate, physical examination, clinical and laboratory testing).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Diphenhydramine Hydrochloride; Naproxen Sodium

Condition Name

Condition Name for Diphenhydramine Hydrochloride; Naproxen Sodium
Intervention Trials
Pain, Postoperative 2
Pain 2
Therapeutic Equivalence 1
Sleep 1
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Condition MeSH

Condition MeSH for Diphenhydramine Hydrochloride; Naproxen Sodium
Intervention Trials
Toothache 2
Pain, Postoperative 2
Neoplasm Metastasis 1
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Clinical Trial Locations for Diphenhydramine Hydrochloride; Naproxen Sodium

Trials by Country

Trials by Country for Diphenhydramine Hydrochloride; Naproxen Sodium
Location Trials
United States 18
China 1
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Trials by US State

Trials by US State for Diphenhydramine Hydrochloride; Naproxen Sodium
Location Trials
Texas 4
Utah 4
New Jersey 1
South Carolina 1
Rhode Island 1
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Clinical Trial Progress for Diphenhydramine Hydrochloride; Naproxen Sodium

Clinical Trial Phase

Clinical Trial Phase for Diphenhydramine Hydrochloride; Naproxen Sodium
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Diphenhydramine Hydrochloride; Naproxen Sodium
Clinical Trial Phase Trials
Completed 6
Recruiting 1
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Clinical Trial Sponsors for Diphenhydramine Hydrochloride; Naproxen Sodium

Sponsor Name

Sponsor Name for Diphenhydramine Hydrochloride; Naproxen Sodium
Sponsor Trials
Bayer 6
Haining Health-Coming Biotech Co., Ltd. 1
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Sponsor Type

Sponsor Type for Diphenhydramine Hydrochloride; Naproxen Sodium
Sponsor Trials
Industry 6
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
US Department of Justice
Farmers Insurance
McKesson
Boehringer Ingelheim
McKinsey
Mallinckrodt
Healthtrust
Citi

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