Clinical trials: Therapeutic Equivalency
Pain
Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets
The primary objective of this study is to compare the bioavailability of a single dose of a new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a commercially available 500 mg fast release…
- Trial name
- Mille (NCT03056703)
- Testing
- Acetylsalicylic acid (Aspirin, BAY1019036)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Food Study Metformin Hydrochloride ER Tablets 750 mg and Glucophage XR 750 mg
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 750 mg (1 x 750 mg) dose administered under…
- Trial name
- NCT00649350
- Testing
- Metformin Hydrochloride ER Tablets 750 mg, Glucophage XR 750 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose…
- Trial name
- NCT06124560
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Melanoma, BRAF V600 Mutation
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.
- Conditions
- Melanoma, BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma
- Trial name
- NCT05810740
- Testing
- Binimetinib 15 MG, Binimetinib 45 MG
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Infectious Diseases
Evaluate Bioequivalence of Burotam (1/1 g/Vial)
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of cefoperazone sodium and sulbactam sodium combination (1/1 g/vial) after intravenous infusion of 1 g cefoperazone sodium and 1 g…
- Trial name
- NCT05654090
- Testing
- cefoperazone sodium and sulbactam sodium
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Diabetes, Healthy
Comparison of Two Liraglutide Formulations in Healthy Volunteers
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.
- Trial name
- NCT01508897
- Testing
- liraglutide
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- Novo Nordisk A/S
Healthy
Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets, Aventis Administered as 1 x 180 mg Tablet in Healthy Subjects under…
- Trial name
- NCT01066754
- Testing
- Fexofenadine
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Non-fasting Conditions
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis following a single oral dose (1 x 800 mg) in…
- Trial name
- NCT00865059
- Testing
- Gabapentin 800 mg Tablets, single dose, NEURONTIN® 800 mg Tablets, single dose
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Prostatic Hyperplasia
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride…
- Trial name
- NCT00537654
- Testing
- Treatment sequence A, Treatment sequence B, Treatment sequence C
- Where
- 2 sites in United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under Fasting Conditions
This is an open-labeled, with blinding bioanalytical stage, randomized, two period, two sequences, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace® Plus, 10…
- Trial name
- NCT05685277
- Testing
- Ramipril/Hydrochlorothiazide tablet 10 mg/25 mg, Tritace® Plus tablet 10 mg/25 mg
- Where
- Russia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Fasting Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg
The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x 15 mg) dose administration under fasting…
- Trial name
- NCT00649077
- Testing
- Meloxicam Tablets 15 mg, Mobic® Tablets 15 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetes Mellitus
Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal
This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin, Huminsulin® Basal.
- Trial name
- NCT02634528
- Testing
- Julphar Insulin N (human isophane insulin), Huminsulin® Basal (NPH, human isophane insulin)
- Where
- Germany
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Julphar Gulf Pharmaceutical Industries
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
Bioequivalence Study
Bioequivalence Study of Spironolactone Tablets in Healthy Subjects
The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® tablets 100mg (by GD SEARLE LLC) in Chinese Healthy Adult…
- Trial name
- NCT06579053
- Testing
- Spironolactone Tablets (Test), Spironolactone Tablets (Reference)
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- SPH Sine Pharmaceutical Laboratories Co., Ltd.
Hematological Malignancy
A Study to Compare Forms of Nemtabrutinib (MK-1026) in Healthy Adult Participants (MK-1026-007)
The goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.
- Trial name
- NCT06586671
- Testing
- Nemtabrutinib
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Prostatic Hyperplasia
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Two tamsulosin HClformulations will be tested in fed state
- Trial name
- NCT02417844
- Testing
- tamsulosin (Astellas), Tamsulosin HCL
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Major Depressive Disorder (MDD)
Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
An open label, randomized, three-period, three-treatment [Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)]…
- Trial name
- NCT05417087
- Testing
- Vortioxetine Hemihydrobromide Orally Disintegrating Tablets, Vortioxetine Hydrobromide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seasons Biotechnology (Taizhou) Co., Ltd.
Healthy
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01511705
- Testing
- Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016.
- Trial name
- NCT03353480
- Testing
- Azithromycin Tablet manufactured in China, Azithromycin Tablet manufactured in US
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Pfizer
Solid Tumor
A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated.
- Trial name
- NCT04035473
- Testing
- HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
- Where
- 7 sites in Australia, New Zealand and 1 more
- Volunteers
- 42 people
- Sponsor
- Athenex, Inc.
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