Clinical trials: Bioequivalence Study in Healthy Subjects
Fed
Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01618825
- Testing
- Lamotrigine Tablets 25 mg, Lamotrigine
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Hypercholesterolemia
Bioequivalence Study On Pediatric Appropriate Formulation
To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.
- Trial name
- NCT00777517
- Testing
- Lipitor, Atorvastatin pediatric formulation
- Where
- Singapore
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fasting Conditions
Objective: To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of Wyeth Pharmaceutical Inc.
- Trial name
- NCT01418417
- Testing
- Torrent's Pantoprazole Sodium Delayed - Release Tablets
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan quinapril hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose under fed conditions.
- Trial name
- NCT00649649
- Testing
- Quinapril Hydrochloride Tablets 40 mg, Accupril® Tablets 40 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited under fasting conditions
- Trial name
- NCT01161940
- Testing
- Nizatidine, Axid
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence Study in Healthy Subjects
Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment
This study evaluates the bioequivalence and adhesion performance of a test rivastigmine transdermal patch compared with the reference product, Exelon® Patch 10 (9.5 mg/24 h), in healthy adult volunteers of both sexes under…
- Trial name
- NCT07464340
- Testing
- Rivastigmine TDS 9,5 mg/24 h, Exelon® 9.5 mg/24 h
- Where
- Brazil
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Zodiac Produtos Farmaceuticos S.A.
Healthy
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
- Trial name
- NCT01101178
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20…
- Trial name
- NCT00649597
- Testing
- Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg, Lotensin HCT® Tablets 20 mg/25 mg
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference) administered as the content of 1 x 10 mg capsule mixed with applesauce under fasting…
- Trial name
- NCT00829452
- Testing
- Ramipril 10 mg capsule, Altace® 10 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Osteoarthritis, Muscle Pain
An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers
This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.
- Conditions
- Osteoarthritis, Muscle Pain, Swelling Muscle
- Trial name
- NCT06510413
- Testing
- Loxoprofen Sodium Patches(reference product), Loxoprofen Sodium Patches(test product )
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Frontier Biotechnologies Inc.
Healthy
Bioavailability Study of Torsemide Tablets Under Fed Conditions
To compare the single-dose bioavailability of Torsemide tablets with Demadex
- Trial name
- NCT00654043
- Testing
- Torsemide, Demadex
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840411
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
- Trial name
- NCT01099709
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Bioequivalency, Safety Issues
Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these…
- Trial name
- NCT06622148
- Testing
- Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer), Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Relapsing Remitting Multiple Sclerosis
Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects
A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.
- Trial name
- NCT05181215
- Testing
- Monomethyl Fumarate 190 Mg, Diroximel Fumarate 462 mg
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Healthy
Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule
The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
- Trial name
- NCT02877225
- Testing
- Ibrutinib, IMBRUVICA
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Asthma
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
- Trial name
- NCT01766843
- Testing
- Seretide Diskus and charcoal, Seretide Diskus, SF Easyhaler and charcoal
- Where
- Finland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.
- Trial name
- NCT01645423
- Testing
- Atorvastatin Calcium Tablets, 80 mg
- Where
- India
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Normal Healthy Subjects
An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects.
- Trial name
- NCT01652859
- Testing
- Liposomal Amphotericin B, AmBisome
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Taiwan Liposome Company
Bioequivalence
Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016.
- Trial name
- NCT03353480
- Testing
- Azithromycin Tablet manufactured in China, Azithromycin Tablet manufactured in US
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Pfizer
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