Clinical trials: Therapeutic Equivalency, Healthy
Healthy Adult Subjects
A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product
To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.
- Trial name
- NCT02444507
- Testing
- Nexium powder for injection and infusion 40 mg, Esomelone Powder for Solution for Injection / Infusion 40 mg
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- isRed Pharma & Biotech Research Corporation
Healthy
Bioequivalence of Two Formulations of Acyclovir
Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg) after Intravenous Infusion in Healthy Volunteers.
- Trial name
- NCT02255734
- Testing
- Acyclovir
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., 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.
Mycoses
Bioequivalence Study for Terbinafine 250 mg
The objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent. Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product Lamisil® 250 mg (Novartis).
- Trial name
- NCT01772212
- Testing
- Terbinafine 250 mg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Fasting
Bioequivalence Study of Sorafenib Tablet and Nexavar
Randomized, open-label, 3-way reference replicated crossover bioequivalence study of sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects under fasting conditions.
- Trial name
- NCT02599337
- Testing
- Nexavar, Sorafenib
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Yabao Pharmaceutical Group
Healthy Volunteers
A Bioequivalence Study of Pegylated Interferon Alfa-2a (PEG-IFN Alfa-2a) Benzyl Alcohol (BA)-Free Formulation Versus PEG-IFN Alfa-2a (Pegasys) Following Subcutaneous Administration
This is an open-label, randomized, multi-center, single dose, two-period, two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation (PEG-IFN…
- Trial name
- NCT02573025
- Testing
- PEG-IFN alfa-2a BA-free formulation (Test), PEG-IFN alfa-2a market formulation (Reference)
- Where
- 9 sites in Australia, Hong Kong and 3 more
- Volunteers
- 277 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fasting Conditions
The objective of this study was to compare the single-dose oral bioavailability of Carvedilol 12.5 mg tablets of Ohm Laboratories with Coreg 12.5 mg tablets in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT00776113
- Testing
- Carvedilol 12.5 mg tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01674517
- Testing
- Montelukast sodium chewable tablets 4mg and 5mg
- Where
- India
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Pharmacokinetic Properties of Isosorbide-5-mononitrate Under Fasting and Fed Condition in Healthy Male Subjects
This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects.
- Trial name
- NCT02101710
- Testing
- Elantan SR 60 mg, Imdur SR 60 mg
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- UCB Korea Co., Ltd.
Healthy
A Relative Bioavailability Study of Mirtazapine 15 mg Tablets Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc.
- Trial name
- NCT00865696
- Testing
- Mirtazapine 15 mg tablets, single dose, REMERON® 15 mg tablets, single dose
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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
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, Healthy Donors
Bioequivalence Study of Revolade® Eltrombopag 50 mg
Bioequivalence Study
- Trial name
- Eltrombopag (NCT06834451)
- Testing
- Revolade®, Eltrombopag (EPAG)
- Where
- Colombia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Healthy
Fasting Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg
The objective of this study was to investigate the bioequivalence of Mylan's nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose…
- Trial name
- NCT00647660
- Testing
- Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg, Corzide® Tablets 80 mg/5 mg
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid…
- Trial name
- NCT00961259
- Testing
- Fenofibric Acid 35 mg Tablet, Fenofibric Acid 105 mg Tablet
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetic Study
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each period.
- Trial name
- NCT01714856
- Testing
- Ropinirole hydrochloride CR 2mg Tablets
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lupin Ltd.
Healthy Volunteer
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
- Trial name
- NCT06337422
- Testing
- Celecoxib 200 mg capsule
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fed Conditions
The purpose of this study was to evaluate the relative bioavailability of the test formulation of sertraline 100 mg tablets with an already marketed reference formulation Zoloft® 100 mg tablets (Pfizer), under non-fasting…
- Trial name
- NCT00778973
- Testing
- sertraline 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Diabetes, Diabetes Mellitus, Type 2
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT01916174
- Testing
- insulin degludec/liraglutide
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Volunteers
A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50…
- Trial name
- NCT01306318
- Testing
- eperisone hydrochloride plus diclofenac sodium capsule, eperisone hydrochloride tablet and diclofenac sodium tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
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