Clinical trials: Bioequivalence Study
Healthy
Metformin ER 750 mg Tablets, Fasting
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fasting conditions.
- Trial name
- NCT00834743
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
Histamine H1 Antagonists, Non-Sedating
To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup
To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
- Trial name
- Bordeaux (NCT02593747)
- Testing
- Loratadine oral solution, Loratadine (Claritin peach syrup)
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc.
- Trial name
- NCT00650117
- Testing
- Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M), Duragesic 25 mcg/h + Scotch Duct Tape (3M), Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Hypercholesterolaemia
Rosuvastatin Calcium Bioequivalence Study - Fast
This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if…
- Trial name
- NCT01711749
- Testing
- Crestor®, rosuvastatin calcium tablets
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects
The present study was conducted with the objective of comparing the bioequivalence and safety of a single dose of ranolazine extended-release tablets (Test product) manufactured by Haisco Pharmaceutical Group Co., Ltd.
- Trial name
- NCT07054255
- Testing
- Test formulation (Ranolazine extended-release tablets), Reference formulation (Ranolazine extended-release tablets)
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy
Clinical Bioequivalence Study on Two Metoprolol Tablet 100mg Formulations
The purpose of the study is to compare the bioavailability of a generic product of metoprolol with that of a reference product when administered to healthy volunteers under fasting conditions.
- Trial name
- NCT03082352
- Testing
- BF-Metoprolol Tablet 100mg, Betaloc Tablet 100mg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Pharma Plant, 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
- NCT04651959
- Testing
- AVICOD 200 MG Film Tablet, AVIGAN 200 MG Film Tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharma Plant
Healthy
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults
The purpose of this study is to understand how the different formulation of phenytoin is taken up into the blood in Healthy Adults. This study is seeking healthy adult participants.
- Trial name
- NCT06466473
- Testing
- Phenytoin (Ascoli), Phenytoin (Vega Baja)
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence Study in Healthy Subjects
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 1000 mg Tablets Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL24-PC020 (NCT07633041)
- Testing
- Synjardy 12.5/1000 mg tablet, Empagliflozin/metformin 12.5/1000 mg
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Gabapentin From Nerpentin 600 mg (Test ) F.C.T (Aman Pharma ,Egypt.) and Gabapentin From Neurontin 300 mg (Referance ) H.G.C. ( Pfizer Egypt)
This study is conducted with the aim to investigate whether any differences concerning the rate and extent of absorption exist between the test and the reference product, Test product was Nerpentine 600 mg Film coated Tablet…
- Trial name
- NCT04805827
- Testing
- Gabapentin, Neurontin
- Where
- Egypt
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharma Guide CRO
Prostatic Hyperplasia
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride…
- Trial name
- NCT00537654
- Testing
- Treatment sequence A, Treatment sequence B, Treatment sequence C
- Where
- 2 sites in United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose crossover bioavailability study on fenofibrate formulations comparing fenofibrate 160 mg tablets of Ranbaxy…
- Trial name
- NCT00775827
- Testing
- fenofibrate 160 mg tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.
- Trial name
- NCT00829894
- Testing
- Risperidone
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Subject
A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different…
- Trial name
- NCT05318820
- Testing
- HMPL-523
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited
Healthy
Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule
- Trial name
- NCT02262559
- Testing
- BIBR 277 tablet, BIBR 277 capsule
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cataract
Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd.
- Trial name
- NCT03499873
- Testing
- Nepafenac 0.3% Oph Susp, Nepafenac 0.3% Oph Susp (reference)
- Where
- United States
- Volunteers
- 448 people
- Sponsor
- Actavis Inc.
Diarrhea
Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day…
- Trial name
- NCT02498418
- Testing
- Rifaximin, Xifaxan®
- Where
- United States
- Volunteers
- 739 people
- Sponsor
- Actavis Inc.
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
Bioequivalence Study
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults
- Trial name
- NCT04358770
- Testing
- Clocortolone Pivalate
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries, Inc.