Clinical trials: Therapeutic Equivalency
Healthy
A Study of Two Macitentan Formulations in Healthy Adult Participants
The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult…
- Trial name
- NCT05433675
- Testing
- Macitentan
- Where
- Belgium
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Actelion
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
Healthy
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules, USP 130 mg manufactured by Ohm Laboratories…
- Trial name
- NCT02306902
- Testing
- fenofibrate, ANTARA® (fenofibrate)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Hyperlipidemia
A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe…
- Trial name
- NCT01236430
- Testing
- Ezetimibe, Ezetimibe/atorvastatin 10mg/10mg FDC, Atorvastatin 10mg
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Bioequivalence
Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273
The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.
- Trial name
- NCT06164431
- Testing
- ZSP1273 tablet, zsp1273 granules
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Healthy
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition
This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.
- Trial name
- NCT01506037
- Testing
- Desloratadine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fasting…
- Trial name
- NCT01131728
- Testing
- Naproxen Sodium & Pseudoephedrine HCl
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Zoliflodacin Bioequivalence and Drug-Drug Interaction Study
this study will be a Phase 1, single-dose, two parallel cohorts, open-label, randomized study in healthy subjects with Cohort 1 as bioequivalence (BE) and food effect study and Cohort 2 as a drug-drug interaction (DDI) study.
- Trial name
- NCT05635305
- Testing
- Zoliflodacin Patheon
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Global Antibiotics Research and Development Partnership
Healthy
GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
The purpose of this study was to assess bioequivalence (BE) of newly developed Glucophage® XR (GXR) reduced mass (RM) tablet (metformin hydrochloride 500 milligrams (mg) test tablet) and marketed Glucophage ® XR tablet (metformin…
- Trial name
- NCT04684420
- Testing
- Glucophage® XR RM Test, Glucophage® XR Reference
- Where
- South Korea
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation
Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation.
- Trial name
- NCT00987779
- Testing
- Gabapentin
- Where
- Singapore
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
The objective of the study was to compare the single-dose oral bioavailability of Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott Laboratories in healthy, adult, human subjects under…
- Trial name
- NCT00774189
- Testing
- clarithromycin 250 mg tablets
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence
Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration
The present study will be conducted in order to compare the bioavailability of the generic Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed Reference product (Ferriprox® film-coated tablets…
- Trial name
- NCT02980458
- Testing
- Deferiprone 500Mg Tablet, Deferiprone 500 MG Oral Tablet [Ferriprox]
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- SocraTec R&D GmbH
Healthy
Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions
Bioavailability comparison study with a cross-over desing, 2x2, open, prospective and longitudinal, at a single dose with two treatments, two periods, two sequences with an elimination (washout) period of 7 days and a number of…
- Trial name
- NCT05027126
- Testing
- Dexketoprofen 25 MG, Fixed dose Dexketoprofen-Vitamin B Complex
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
To compare the relative bioavailability of Kali and Ortho-McNeil's
- Trial name
- NCT00653315
- Testing
- Tramadol APAP, Ultracet
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Type 2 Diabetes Mellitus (T2DM)
Bioequivalence Study to Compare Empagliflozin/ Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets…
- Trial name
- NCT07694115
- Testing
- Empagliflozin / Metformin Extended-Release Tablet, Synjardy XR tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Headache, Tension-Type
A Pharmacokinetic Study of an Experimental Paracetamol Formulation
This PK study is designed to show bioequivalence between the study treatments.
- Trial name
- NCT01476176
- Testing
- Experimental paracetamol, Paracetamol marketed formulation
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type II Diabetes
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
- Trial name
- NCT05108350
- Testing
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR, T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Rheumatoid Arthritis
MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of…
- Trial name
- NCT02468791
- Testing
- Rituximab
- Where
- 51 sites in Bosnia and Herzegovina, Georgia and 3 more
- Volunteers
- 709 people
- Sponsor
- Mabion SA
Chronic Obstructive Pulmonary Disease
Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
The study will assess the Pharmacokinetic (PK) and safety of BGF MDI [Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane…
- Trial name
- NCT05477108
- Testing
- Treatment A (BGF MDI HFO with oral activated charcoal), Treatment B (BGF MDI HFA with oral activated charcoal)
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Contraception
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)
The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the…
- Trial name
- NCT01253174
- Testing
- EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131), EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca), L-5-MTHF Ca 0.451 mg (Metafolin)
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bayer
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