Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg
The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following evening administration of a single…
- Trial name
- NCT00647673
- Testing
- Verapamil HCL Extended-Release Capsules 300 mg, Verelan® PM Extended-Release Capsules 300 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation
This study is intended to establish the bioequivalence (BE) of single 100 mg doses of glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation compared to the Phase 2 formulation.
- Trial name
- B1371026 (NCT03130556)
- Testing
- Glasdegib, High Fat, High Calorie Meal, Rabeprazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tuberculosis
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane®…
- Trial name
- NCT01311505
- Testing
- Myrin© 2 (Rifampicin + Isoniazid), Rimactane® (Rifampicin)
- Where
- Philippines
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
The purpose of this study is to 1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets. 2.
- Trial name
- NCT01133483
- Testing
- Fexofenadine HCl + Pseudoephedrine HCl
- Where
- India
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type 2 Diabetes Mellitus, Healthy Subjects
A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
Primary Objective: To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects Secondary…
- Trial name
- NCT03776227
- Testing
- sotagliflozin (SAR439954)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Sanofi
Viral Infection, COVID-19
Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers
The study aimed for: 1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), based on the analysis…
- Trial name
- NCT05412173
- Testing
- Molnupiravir
- Where
- Russia
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy Volunteers
Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080469
- Testing
- Tacrolimus 1 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Acne Vulgaris
Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%
To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products…
- Trial name
- NCT04329403
- Testing
- Adapalene 0.1% Gel, Differin 0.1% Topical Gel
- Sponsor
- Aurobindo Pharma Ltd
Moderate-to-severe Benign Prostatic Hyperplasia (BPH)
Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
- Trial name
- NCT07643233
- Testing
- Test Drug, Reference Drug
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AJU Pharm Co., Ltd.
Healthy
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release…
- Trial name
- NCT04881747
- Testing
- Lasmiditan
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)
The purpose of this study is to demonstrate bioequivalence (BE) between Euthyrox® tablets manufactured at Merck Nantong (Test Euthyrox) versus the tablets manufactured at Merck Darmstadt (Reference Euthyrox).
- Trial name
- NCT05174000
- Testing
- Test Euthyrox®, Reference Euthyrox®
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Fasting Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's doxycycline monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting…
- Trial name
- NCT00649571
- Testing
- Doxycycline Monohydrate Tablets (100 mg, Adoxa Tablets 100 mg
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD2 in healthy volunteers.
- Trial name
- NCT05581693
- Testing
- L04RD1, L04TD2
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers
This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.
- Trial name
- NCT05572281
- Testing
- Tasimelteon Oral Capsule, Tasimelteon Oral Suspension
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Diabetes Mellitus
A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin.
- Trial name
- NCT01476345
- Testing
- LY2963016, Lantus
- Where
- South Africa
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg
The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose administered under fed conditions.
- Trial name
- NCT00649857
- Testing
- Cetirizine HCl Tablets 10 mg, Zyrtec® 10 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetes Mellitus, Type 2
A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water
- Trial name
- NCT01388153
- Testing
- Acarbose (Glucobay ODT, BAYG5421), Acarbose (Glucobay, BAYG5421)
- Where
- Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of Wyeth consumer health care, USA, in normal…
- Trial name
- NCT01053208
- Testing
- Ibuprofen and Diphenhydramine Citrate
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Risperidone 1 mg Tablet in Healthy Subjects Under Fasting 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 tablet under fasting conditions.
- Trial name
- NCT00830349
- Testing
- Risperidone
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition
Objective: To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product…
- Trial name
- NCT00940238
- Testing
- Citalopram Hydrobromide
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
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