Clinical trials: Therapeutic Equivalency, Healthy
Hepatitis C
Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule…
- Trial name
- NCT01181804
- Testing
- boceprevir
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union).
- Trial name
- NCT01844804
- Testing
- PF-06438179, Remicade
- Where
- United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc.
- Trial name
- NCT00759902
- Testing
- morphine sulfate extended-release capsules, KADIAN (morphine sulfate extended-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.
- Trial name
- NCT01928069
- Testing
- Torrent's Montelukast Sodium Tablets 10 mg
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Heathy Volunteers
Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers
The aim of this pharmacokinetic study is to assess the bioequivalence of the generic Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test product), to Venofer® Iron Sucrose injection…
- Trial name
- NCT03093883
- Testing
- Ferrinemia, Venofer
- Where
- Austria
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Azad Pharma AG
Healthy
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union).
- Trial name
- NCT01870986
- Testing
- PF-06410293, Humira (adalimumab-EU), Humira (adalimumab-US)
- Where
- 2 sites in United States, Belgium
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.
- Trial name
- NCT01276327
- Testing
- Linagliptin + Pioglitazone, Linagliptin/Pioglitazone
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block
The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.
- Trial name
- NCT02466503
- Testing
- Fluticasone propionate, Salmeterol (as xinafoate)
- Where
- Taiwan
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition
An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
- Trial name
- NCT01052129
- Testing
- Naproxen sodium
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteer
Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects.
- Trial name
- NCT06388239
- Testing
- Apixaban 5MG
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fed Condition
To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr. Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg tablets (Bristol-Myers Squibb, USA) in 48 +…
- Trial name
- NCT01160068
- Testing
- Metformin, Glucophage
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Individuals
Bioequivalence Study of Rosuvastatin Tablet
This study is designed to explore the bioequivalence of Test Product Vaptor (Rosuvastatin) 20 mg Tablet with the reference product Crestor (Rosuvastatin) 20 mg tablet under fasting conditions in healthy Pakistani male subjects.
- Trial name
- BE (NCT05637060)
- Testing
- Test Drug, Reference Drug
- Where
- Pakistan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Karachi
Healthy
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912
- Trial name
- NCT01447797
- Testing
- HCP0912 / Irbesartan and Atorvastatin
- Where
- South Korea
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Healthy
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01671709
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg Tablets (Teva GmbH, Germany)
Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Modafinil From Bravamax 200 mg Scored Tablets (Chemipharm Pharmaceutical Industries, Egypt) Versus Vigil 200 mg…
- Trial name
- NCT05855187
- Testing
- Bravamax 200 mg (Modafinil), Vigil 200 mg (Modafinil)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
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 on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions
To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with Claritin® Reditabs® (containing loratadine 10 mg) of…
- Trial name
- NCT00776217
- Testing
- loratadine 10 mg orally disintegrating tablets
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.
- Trial name
- NCT01355068
- Testing
- Epanutin Infatabs (Phenytoin), Dilantin Infatabs (Phenytoin)
- Where
- Singapore
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fed Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Valacyclovir hydrochloride tablets 1 gram manufactured by OHM…
- Trial name
- NCT01222897
- Testing
- Valacyclovir hydrochloride
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
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