Clinical trials: Therapeutic Equivalency, Healthy
Pharmacokinetics
Fasting Comparative Bioavailability Study of 2 Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition
The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence.
- Trial name
- NCT05125588
- Testing
- Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine), Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Healthy
Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations
The purpose of the study is to compare the bioavailability of a generic product of gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical…
- Trial name
- NCT02643329
- Testing
- BF-Gliclazide Tablet 80mg, Diamicron 80mg Tablet
- Where
- Hong Kong
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Falciparum Malaria
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).
- Trial name
- NCT00894374
- Testing
- Artesunate (Test), Artesunate (Comparator)
- Where
- Singapore
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy, Obesity
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product [formulation A]) and in a vial (test product [formulation B2]) in male and female trial participants…
- Trial name
- NCT07768813
- Testing
- Survodutide formulation A, Survodutide formulation B2
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions
The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc.
- Trial name
- NCT00779441
- Testing
- Zolpidem 10mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study on the Correlation of Drug Metabolism and Human Body Composition Based on the Bioequivalence Trial of Progesterone Sustained-release Vaginal Gel
The aim of this observational study is to investigate the impact of body composition on the absorption, distribution, and metabolism of drugs.
- Trial name
- NCT07097246
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Healthy
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a 1X100 mg tablet, under fasted conditions.
- Trial name
- NCT00944242
- Testing
- Sertraline, Sertraline Hydrochloride
- Where
- Canada
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Volunteers
The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
The purpose of this study is to assess the bioequivalence of the contraceptive hormones of ORTHO EVRA when the patch is applied with and without an adhesive overlay.
- Trial name
- NCT01535820
- Testing
- Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay, Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Chinese Healthy Volunteers
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1*250mg/tablet) in healthy male volunteers to…
- Trial name
- NCT02196805
- Testing
- Group A: imported Probucol ( Lorelco), Group B: Marketed Probucol ( Chang Tai)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Otsuka Beijing Research Institute
Healthy
A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30…
- Trial name
- NCT03794154
- Testing
- Cymbalta capsule, Duloxetine hydrochloride capsule
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fasting conditions.
- Trial name
- NCT00847405
- Testing
- Sumatriptan Succinate, Imitrex®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Migraine
A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults
The purpose of this study is to assess the bioequivalence of an alternative ODT formulation (ODT2) versus the approved ODT formulation of a CGRP receptor antagonist in healthy adult participants under fasting conditions.
- Trial name
- NCT07594769
- Testing
- ODT2 Test formulation, ODT Reference formulation
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence of Flurbiprofen Lozenge vs Strepfen
The present study has been designed to compare flurbiprofen pharmacokinetic profile after administration of flurbiprofen 8.75 mg lozenges, marketed by ACRAF, S.p.A., Italy (test product), and the marketed Strepfen 8.75 mg honey…
- Trial name
- NCT04670601
- Testing
- Flurbiprofen Test 8.75 MG, Flurbiprofen Reference 8.75 MG
- Where
- Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Solid Tumor
An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fasting 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 fasting condition.
- Trial name
- NCT05390944
- Testing
- IMP4297(20mg), IMP4297(10mg)
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Impact Therapeutics, Inc.
Healthy Volunteer
A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet
The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503) dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in healthy Japanese male participants.
- Trial name
- NCT01273532
- Testing
- tapentadol (CG5503) ER 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.
- Trial name
- NCT07845630
- Testing
- Vicadrostat, Empagliflozin, Vicadrostat + empagliflozin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg - 42.9 mg/ 5 mL Oral Suspension Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption Ranbaxy Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A.
- Trial name
- NCT00778414
- Testing
- Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants
The purpose of this study is to evaluate the single-dose pharmacokinetic (PK) and bioequivalence of Darunavir (DRV) in the presence of Cobicistat (COBI) when administered as a DRV/COBI fixed dose combination (FDC) tablet…
- Trial name
- NCT05378906
- Testing
- DRV/COBI FDC, COBI, DRV
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.
- Trial name
- NCT01421043
- Testing
- triazolam liquid oral drops, triazolam tablets
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pfizer
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