Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Bioequivalence Study of Metformin HCl 750 mg XR Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of metformin HC1 750 mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol Myers Squibb) in healthy, adult, subjects under…
- Trial name
- NCT00778791
- Testing
- metformin HC1 750 mg extended-release tablets
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Adults
Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and…
- Trial name
- NCT03168022
- Testing
- Treatment A, Treatment B
- Where
- Canada
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Healthy
Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions
To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine…
- Trial name
- NCT00778037
- Testing
- Cyclobenzaprine hydrochloride 10 mg tablet
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Subjects
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to…
- Trial name
- B538-07 (NCT02237729)
- Testing
- PF-06410293, Adalimumab-US, Adalimumab-EU
- Where
- 8 sites in United States
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- Pfizer
Fasting
Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01722201
- Testing
- Risperidone Tablet 1 mg, Risperidone
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System
To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.
- Trial name
- NCT00864565
- Testing
- Fentanyl 25 μg/h transdermal system, single application, Duragesic 25 μg/h transdermal system single application
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
PAH
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fed conditions.
- Trial name
- NCT06553937
- Testing
- Macitentan and Tadalafil, PrOpsynvi® Film-Coated Tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Acne Vulgaris
A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition
This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin.
- Trial name
- NCT02498288
- Testing
- Isotretinoin: Reference Medication 1, Isotretinoin: Reference Medication 2, Isotretinoin: Test Medication
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
Bioequivalence Study of Sulfadoxine/ Pyrimethamine Tablets in Healthy Subjects Under Fasting Conditions
To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation.
- Trial name
- NCT04577469
- Testing
- Maldox tablets, G-COSPE® tablets
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Emzor Pharmaceutical Industries Limited
Healthy Subjects (HS)
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508A and YHR2601 in healthy subjects
- Trial name
- NCT07912827
- Testing
- YHP2508A, YHR2601
- Where
- 2 sites in South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Bioequivalence
Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects
Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)
- Trial name
- NCT04101370
- Testing
- Bosentan 125 mg, Tracleer 125Mg Tablet
- Where
- Russia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy
Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fed Conditions
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under non-fasted…
- Trial name
- NCT01276080
- Testing
- Donepezil
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Fed
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01744873
- Testing
- Bisoprolol Fumarate Tablet 10 mg, Bisoprolol
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence, single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg under fed conditions.
- Trial name
- NCT02197494
- Testing
- Valsartan
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Subjects
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm).
- Trial name
- NCT02279485
- Testing
- Perampanel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
Valacyclovir 1000 mg Tablet Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed conditions.
- Trial name
- NCT01149460
- Testing
- Valacyclovir
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence
A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions
This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan medoxomil/ hydrochlorothiazide in the two…
- Trial name
- NCT04138888
- Testing
- Olmesartan Medoxomil/Hydrochlorothiazide 40 Mg/25 Mg film-coated tablets for oral use, Olmetec® Plus 40 Mg/25 Mg film-coated tablets for oral use
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.
- Trial name
- NCT01399788
- Testing
- Myrin P Forte, Single drug references
- Where
- Singapore
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men…
- Trial name
- NCT03456960
- Testing
- TAK-438ASA, TAK-438, Aspirin
- Where
- Japan
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Meloxicam 15 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fasting conditions.
- Trial name
- NCT00840476
- Testing
- Meloxicam 15 mg Tablets, Mobic® 15 mg Tablets
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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