Clinical trials: Therapeutic Equivalency
Healthy
A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400 mg Film Coated Tablets ( Multi-Apex…
- Trial name
- NCT02605798
- Testing
- Elbanovir, Sovaldi
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions
The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8 mg orally disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg…
- Trial name
- NCT01523093
- Testing
- Ondansetron
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.
- Trial name
- NCT02088697
- Testing
- ASC-01
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy
Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg
The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.
- Trial name
- NCT00650195
- Testing
- Metolazone Tablets 10 mg, Zaroloxyn® Tablets 10 mg
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants
The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled…
- Trial name
- NCT04840901
- Testing
- Lebrikizumab
- Where
- 4 sites in United States
- Volunteers
- 242 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.
- Trial name
- NCT01131936
- Testing
- Amlodipine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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
Drug Effect, Safety Issues
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1.
- Conditions
- Drug Effect, Safety Issues, Immunogenicity
- Trial name
- NCT06497036
- Testing
- GP404141, Nplate
- Where
- 6 sites in Russia
- Volunteers
- 160 people
- Sponsor
- Geropharm
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
Type2 Diabetes
A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State
A study demonstrates the bioequivalence of DA-1229_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults
- Trial name
- NCT03939143
- Testing
- DA-1229_01(A), Sugamet SR Tab 5/1000mg®, Sugamet SR Tab 5/1000mg®, DA-1229_01(A)
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
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
Multiple Myeloma
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
Safety and bioequivalence of SPARC_147709
- Trial name
- NCT00863174
- Testing
- SPARC147709, Reference147709
- Volunteers
- 24 people
- Sponsor
- Sun Pharma Advanced Research Company 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
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