Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Volunteers
Bioequivalence Study of Cyclosporine 100mg Capsule Under Fasting Condition
To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference Product (B):Neoral (Cyclosporine…
- Trial name
- NCT01080560
- Testing
- Cyclosporine Capsules USP (Modified) 100 mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Healthy
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.
- Trial name
- NCT04816513
- Testing
- Ustekinumab
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose
Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet
This was a single centre, single-blind, randomized, balanced, combined single dose study under fasting condition and multiple doses study under fed condition with normal diabetic-meal, two-period, two-sequence cross-over study to…
- Trial name
- NCT01677260
- Testing
- 500 mg metformin hydrochloride extended release caplet (test drug), 500 mg metformin hydrochloride prolonged release tablet (reference drug)
- Where
- Indonesia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Bioequivalence
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fed Conditions
The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan…
- Trial name
- NCT04411953
- Testing
- Haloperidol Tablets, Mylan Pharmaceuticals Inc., Haloperidol Tablets, Cycle Pharmaceuticals Ltd
- Where
- South Africa
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers
This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers
- Trial name
- NCT06119945
- Testing
- DWJ1568, DWC202215
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
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
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Solid Tumor
An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fed Condition
An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fed condition
- Trial name
- NCT05391048
- Testing
- IMP4297(20mg), IMP4297(10mg)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Impact Therapeutics, Inc.
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
- Trial name
- NCT02322658
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol…
- Trial name
- NCT05300087
- Testing
- Albuterol Sulfate Inhalation Aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co.
- Trial name
- NCT01167933
- Testing
- Simvastatin
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/500 mg) with respect…
- Trial name
- NCT02065752
- Testing
- Canagliflozin, 100 mg, Metformin XR, 500 mg, CANA/MET XR FDC, Formulation 1, 50 mg/500 mg
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects…
- Trial name
- NCT02218658
- Testing
- WE941 OD tablets, Brotizolam
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects
The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd.
- Trial name
- NCT07519278
- Testing
- Test formulation（pramipexole dihydrochloride extended-release tablets）, Reference formulation（MIRAPEX ER®）
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Bioequivalence
Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions
This is an open-labeled, randomized, four period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Plavix®, 75 mg film-coated tablets) or the test…
- Trial name
- NCT05934799
- Testing
- Clopidogrel film-coated tablet 75 mg, Plavix® film-coated tablet 75 mg
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions
The purpose of this study is to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions.
- Trial name
- NCT01645384
- Testing
- Atorvastatin Calcium Tablets, 40 mg
- Where
- India
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Depressive Disorder
Paxil CR Bioequivalence Study Brazil
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).
- Trial name
- NCT01316926
- Testing
- Test formulation, Reference formulation
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study in Healthy People to Compare Two Tablet Formulations of Pramipexole
The goal of this study is to find out whether pramipexole tablets made at two different production sites are handled in the same way by the body.
- Trial name
- NCT07727785
- Testing
- Sifrol®, Mirapex®
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups.
- Trial name
- NCT02121535
- Testing
- T80/A5 mg FDC tablet, H12.5 mg tablet, T80/A5/H12.5 ng FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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