Clinical trials: Bioequivalence
- Condition Bioequivalence
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Healthy Adult Subjects
Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects
The primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations…
- Trial name
- NCT04521192
- Testing
- Fluzoparib
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Schizophrenia
A Bioequivalence Study of 15 mg ER OROS Paliperidone
The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the effect of food on the highest to be marketed…
- Trial name
- NCT00892489
- Testing
- ER OROS Paliperidone
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hypertension
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
- Trial name
- NCT02801526
- Testing
- CKD-330 16/5mg - A, Candesartan 16mg and Amlodipine 5mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Healthy
Donepezil 10 mg Tablets Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of donepezil 10 mg tablet (test) versus Aricept® (reference), administered as 1 x 10 mg tablet under fed conditions.
- Trial name
- NCT01439243
- Testing
- Donepezil, Aricept®
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Tobacco Use Disorder
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).
- Trial name
- NCT05024747
- Testing
- NicoDerm CQ patch (GSK Dungarvan), NicoDerm CQ (Alza)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- HALEON
Healthy
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants
The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet…
- Trial name
- NCT01981278
- Testing
- Tapentadol ER 250-mg TRF tablet, Tapentadol ER 250-mg PR2 tablet
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Clonazepam ODT Under Fasting Conditions
To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg ODT
- Trial name
- NCT00652912
- Testing
- Clonazepam, Klonopin Wafers
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Bioequivalence
Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each…
- Trial name
- NCT03799536
- Testing
- Sotalol, Sotalex
- Where
- Belarus
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Pharmacodynamics, Pharmacokinetics
Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141
Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.
- Conditions
- Pharmacodynamics, Pharmacokinetics, Bioequivalence
- Trial name
- NCT05652595
- Testing
- GP40141, Nplate
- Where
- Russia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Geropharm
Atrial Fibrillation (AF)
Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions
The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ®) in healthy Chinese subjects under fasting conditions.
- Trial name
- NCT07396506
- Testing
- Dronedarone Hydrochloride Tablets, MULTAQ® (Dronedarone Hydrochloride Tablets)
- Where
- China
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Epilepsy
Bioequivalence and Food Effect of 250mg of Lamotrigine XR
This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers
- Trial name
- NCT00605371
- Testing
- Lamotrigine tablet, Lamotrigine caplet
- Where
- United States
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).
- Trial name
- NCT00845663
- Testing
- Certolizumab pegol
- Where
- France
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Bioequivalence
Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each…
- Trial name
- NCT03616301
- Testing
- Clavamox, Augmentin®
- Where
- Russia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fasting…
- Trial name
- NCT00648531
- Testing
- Balsalazide Disodium Capsules 750 mg, Colazal® Capsules 750 mg
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under…
- Trial name
- NCT00650234
- Testing
- Metformin Hydrochloride ER Tablets 500 mg, Glucophage® XR Tablets 500 mg
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co.
- Trial name
- NCT01188031
- Testing
- ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, NIRAVAM TM 2 mg orally disintegrating tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA [Albuterol Sulfate] Inhalation Aerosol 90 mcg Per…
- Trial name
- NCT04803734
- Testing
- Albuterol Sulfate inhalation aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
Bioequivalence Study of Idalopirdine Tablets 60 mg
This study aims to establish bioequivalence between two tablet formulations of idalopirdine
- Trial name
- NCT02371707
- Testing
- Idalopirdine 60 mg formulation A (test), Idalopirdine 60 mg formulation B (reference)
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
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