Clinical trials: Bioequivalence Study in Healthy Subjects
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.
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
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
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
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
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
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants
The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or…
- Trial name
- NCT05069896
- Testing
- Mirikizumab Prefilled Syringe, Mirikizumab Autoinjector
- Where
- 3 sites in United States
- Volunteers
- 237 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Antithrombic Drug
Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under…
- Trial name
- NCT06043297
- Testing
- Apixaban 5MG, Eliquis 5 mg
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib
The main purpose of the study was to demonstrate bioequivalence between the new tablet formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2, reference treatment) and to investigate effect of…
- Trial name
- NCT03629223
- Testing
- Tepotinib TF2, Tepotinib TF3
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
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