Clinical trials: Therapeutic Equivalency
Prostatic Hyperplasia
A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
This study is an open-label, randomized, single dose, multi-stage, cross-over study in healthy male subjects of North East Asian ancestry.
- Trial name
- NCT01495026
- Testing
- Dutasteride (0.5mg, fasted state), Dutasteride (0.5mg, fed state), Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets…
- Trial name
- NCT01365091
- Testing
- Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin, Metformin extended-release (XR)
- Where
- Brazil
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
T2DM (Type 2 Diabetes Mellitus)
Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation…
- Trial name
- NCT07519265
- Testing
- Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Chiglitazar tablet, dose 1, Metformin extended-release tablet, dose 1
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Anaemia
Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
This study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence.
- Trial name
- NCT04640311
- Testing
- Daprodustat
- Where
- 4 sites in United States
- Volunteers
- 259 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Health
Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet
This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects.
- Trial name
- NCT06817811
- Testing
- Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica), Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia)
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Melanoma, BRAF V600 Mutation
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.
- Conditions
- Melanoma, BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma
- Trial name
- NCT05810740
- Testing
- Binimetinib 15 MG, Binimetinib 45 MG
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Trichomoniasis
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.
- Trial name
- NCT01591889
- Testing
- Tinidazole
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bronchial Asthma
BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.
- Trial name
- NCT03394989
- Testing
- Fluticasone propionate/salmeterol 100/50 µg, Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
- Where
- United States
- Volunteers
- 1,366 people
- Sponsor
- Cipla Ltd.
Type 2 Diabetes Mellitus (T2DM), Cardiovascular Diseases
Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus…
- Trial name
- NCT07872358
- Testing
- Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet, Trijardy® XR Tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalence
Bioequivalence Study of Metformin 1000 mg Tablets Immediate Release (IR) Versus Glucophage® 1000 mg Tablets IR In Healthy Subjects
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )
- Trial name
- NCT03458208
- Testing
- Metformin, Glucophage®
- Where
- Russia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.
- Trial name
- NCT01085708
- Testing
- rabeprazole
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Healthy
Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fasting conditions.
- Trial name
- NCT00973050
- Testing
- Bicalutamide, Casodex®
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence Study
Bioequivalence Study of Spironolactone Tablets in Healthy Subjects
The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® tablets 100mg (by GD SEARLE LLC) in Chinese Healthy Adult…
- Trial name
- NCT06579053
- Testing
- Spironolactone Tablets (Test), Spironolactone Tablets (Reference)
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- SPH Sine Pharmaceutical Laboratories Co., Ltd.
Healthy
A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants
The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it, when given as different formulations.
- Trial name
- NCT05089019
- Testing
- Selpercatinib
- Where
- 4 sites in United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
Atopic Dermatitis
Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis
A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus…
- Trial name
- NCT03297502
- Testing
- pimecrolimus cream 1%, Elidel (pimecrolimus) cream 1%
- Volunteers
- 582 people
- Sponsor
- Par Pharmaceutical, Inc.
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (World Medicine, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04407000)
- Testing
- Test: Favipiravir 200 mg (LOQULAR), Reference: Favipiravir 200 mg (Avigan)
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- World Medicine ILAC SAN. ve TIC. A.S.
Healthy
Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator
The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.
- Trial name
- NCT03131700
- Testing
- RPH001, Avastin®
- Volunteers
- healthy volunteers welcome
- Sponsor
- TRPHARM
Cardiovascular Disease
Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects
Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way cross over, six sequence study to investigate the…
- Trial name
- NCT02502812
- Testing
- Clop F1, Clop F2, Innovator
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal…
- Trial name
- NCT01291524
- Testing
- Pregabalin controlled release, 330 mg, 400 to 500 calorie, Pregabalin controlled release, 330 mg, 600- 750 calorie, Pregabalin controlled release, 330 mg, bedtime
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Infections, Urinary Tract
A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration.
- Trial name
- NCT02446496
- Testing
- Cefadroxil tablets manufactured by GSK, Cefadroxil tablets manufactured by NP
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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