Clinical trials: Therapeutic Equivalency
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
Healthy
Leflunomide 20 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc.
- Trial name
- NCT00834418
- Testing
- Leflunomide 20 mg Tablets, ARAVA™ 20 mg Tablets
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence, Adhesion
Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects
This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes.
- Conditions
- Bioequivalence, Adhesion, Adverse Effects
- Trial name
- No acronyms (NCT07769359)
- Testing
- Rotigotine Transdermal Delivery System (TDS)
- Where
- India
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Amarin Technologies S.A.U.
Overweight/Obesity
Bioequivalence Study of BGM0504 Injection
This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference…
- Trial name
- NCT07382908
- Testing
- BGM0504 Injection multi-dose pen, BGM0504 Injection single-dose pen
- Where
- China
- Volunteers
- 144 people
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
Infection, Human Immunodeficiency Virus
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects.
- Trial name
- NCT03078556
- Testing
- Dolutegravir, Lamivudine, Dolutegravir + Lamivudine FDC Formulation 1
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Cardiomyopathy
A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
- Trial name
- NCT07479641
- Testing
- Test formulation of HRS-1893 tablet, Reference formulation of HRS-1893 tablet
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy Subjects
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233227
- Testing
- Dutasteride-Test product, Dutasteride-Reference product
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Fed Study of Oxybutynin Chloride Extended-release Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649727
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Chronic Hepatitis b
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®)…
- Trial name
- NCT03847246
- Testing
- Baraclude® tablets,1.0 mg, Entecavir tablets,1.0 mg
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Psoriasis
Bioequivalence Test of Hemay005 Tablets
The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.
- Trial name
- NCT06610903
- Testing
- Hemay005
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Healthy Volunteers, Type 2 Diabetes
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide.
- Trial name
- NCT05227196
- Testing
- Semaglutide D Dose 1, Semaglutide D Dose 2, Semaglutide D Dose 3
- Where
- 3 sites in United States, Canada
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.
- Trial name
- NCT06393127
- Testing
- Nerandomilast
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Amlodipine 10mg Tablets Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one tablet dose in fed state subjects.
- Trial name
- NCT00775151
- Testing
- amlodipine 10 mg tablet
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Tobacco Dependence
Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum
Bioequivalence between oral nicotine replacement products and Nicorette® gum.
- Trial name
- NCT01113424
- Testing
- Nicotine, Nicorette® (Nicotine Gum)
- Where
- Sweden
- Volunteers
- 88 people
- Sponsor
- McNeil AB
Healthy
Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single…
- Trial name
- NCT00974441
- Testing
- Divalproex Sodium, Depakote®
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Meloxicam 15 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fed conditions.
- Trial name
- NCT00840879
- Testing
- Meloxicam 15 mg Tablets, Mobic® 15 mg Tablets
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose…
- Trial name
- NCT00649870
- Testing
- Valacyclovir Hydrochloride Tablets 1000 mg, Valtrex® Tablets 1000 mg
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.
- Trial name
- NCT02617758
- Testing
- Fentanyl
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Bioequivalence Study in Healthy Subjects
Bioequivalence Assessment Between Two Cariprazine Hard Capsule Formulations
An open label, randomized, single-dose, two sequence, two-period, crossover study to assess the bioequivalence of Cariprazine in Vocarzine 1.5 mg hard gelatin capsule (Test product) in comparison with Reagila® 1.5 mg hard…
- Trial name
- BEVocCapATCO (NCT07121868)
- Testing
- Test Product (Vocarzine), Reference (R) Reagila ®
- Where
- Egypt
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Aya Mohammed Abdel Magid Abdel Hamid
Epilepsy (treatment Refractory)
Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions
The goal of this clinical trial is to evaluate the bioequivalence of Brivaracetam oral solution under fasting and high-fat meal conditions in healthy adults.
- Trial name
- BE (NCT06762743)
- Testing
- Brivaracetam Oral Solution (Test Formulation), Brivaracetam Oral Solution (Reference Formulation)
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
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