Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01888250
- Testing
- Lamotrigine
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck…
- Trial name
- NCT05798715
- Testing
- Gleptomet 50/1000(Metformin HCl & Sitagliptin), Janumet 50/1000(Metformin HCl & Sitagliptin)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy Adult Subjects
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects
- Trial name
- NCT04493281
- Testing
- MT-1186, MCI-186
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy
Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions
The study was an open label, balanced, randomized, two-treatment, four-period, two sequence, single oral dose, crossover, fully replicate bioequivalence study of two formulations of Valsartan 320 mg under fasting conditions.
- Trial name
- NCT02197442
- Testing
- Valsartan
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg
The purpose of this study is to evaluate the bioequivalence of a new paracetamol 1000 mg/codeine 30 mg formulation vs. the marketed reference Co-efferalgan® 500 mg/30 mg in terms of rate and extent of absorption, when…
- Trial name
- NCT02902666
- Testing
- Paracetamol 1000 mg/codeine phosphate hemihydrate 30 mg tablet, Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Dyslipidemia
MK0524A Bioequivalence Study (0524A-059)
This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
- Trial name
- NCT00944645
- Testing
- niacin (+) laropiprant (Source 1), Comparator: niacin (+) laropiprant (Source 2)
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Bioequivalence
A Pilot Bioequivalence Study of Pomalidomide
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
- Trial name
- NCT03424928
- Testing
- Pomalidomide 4 MG Oral Capsule, Pomalidomide 4 MG Oral Capsule-Pomalyst
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Chronic Obstructive Pulmonary Disease
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).
- Trial name
- NCT03137992
- Testing
- Test Product (tiotropium bromide inhalation powder), Reference Product (Spiriva®)
- Where
- 34 sites in United States
- Volunteers
- 377 people
- Sponsor
- Lupin, Inc.
Healthy
Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of moexipril HCl/ hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets…
- Trial name
- NCT00834067
- Testing
- Moexipril HCl/hydrochlorothiazide 15/25 mg tablets, UNIRETIC® 15/25 mg tablets
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Topiramate 25 mg Tablets Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.
- Trial name
- NCT00905567
- Testing
- Topiramate 2 x 25 mg tablet, Topamax® Tablet 2 x 25 mg
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.
- Trial name
- NCT00803439
- Testing
- Clobetasol Propionate 0.05% Foam-Reference Product, Clobetasol Propionate 0.05% Foam-Test product
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Healthy
Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg-42.9 mg/ 5 mL Oral Suspension Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Ranbaxy Laboratories Limited, India, Amoxicillin-Clavulanic acid and GlaxoSmithKline, U.S.A.
- Trial name
- NCT00778544
- Testing
- amoxicillin-clavulanic acid 600 mg- 42.9 mg/ 5 mL oral suspension
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Type 1 Diabetes
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
Primary Objective: To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose…
- Trial name
- NCT03903016
- Testing
- Insulin Lispro SAR342434
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Sanofi
Healthy Subjects
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
- Trial name
- NCT00383916
- Testing
- pantoprazole
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions
To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT
- Trial name
- NCT00654277
- Testing
- Ondansetron, Zofran
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Thrombocytopenia
Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fasting conditions.
- Trial name
- NCT06768632
- Testing
- Group 1: single-dose of test formulation+single-dose of reference formulation, Group 2: single-dose of reference formulation+single-dose of test formulation
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.
- Trial name
- NCT00649532
- Testing
- Ondansetron Tablets 24 mg, Zofran® Tablets 24 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially…
- Trial name
- NCT00834795
- Testing
- Carvedilol 25 mg tablets, COREG® 25 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Human Volunteers
A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers
The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.
- Trial name
- NCT01618877
- Testing
- Levetiracetam
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Healthy Volunteer
A Study to Compare Blood Levels of Different Dosage Formulations of the Study Medicine That Is a CGRP Receptor Antagonist in Healthy Adults
The purpose of this study is to assess the bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of different formulations of a CGRP receptor antagonist in…
- Trial name
- NCT07261371
- Testing
- Test formulation (Treatment A), Reference formulation (Treatment B), Test formulation (Treatment C)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Pfizer
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