Clinical trials: Therapeutic Equivalency
Healthy
Food Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR 500 mg
The objective of this study is to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under…
- Trial name
- NCT00648492
- Testing
- Metformin Hydrochloride ER Tablets 500 mg, Glucophage® XR 500 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Asthma
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions
- Trial name
- NCT01659892
- Testing
- Montelukast, Singulair
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy Adult
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants under fasting condition.
- Trial name
- NCT07606105
- Testing
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Injectafer®]
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Healthy
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under…
- Trial name
- NCT00648934
- Testing
- Topiramate Sprinkle Capsules 25 mg, Topamax® Sprinkle Capsules 25 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Hypercholesterolemia
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).
- Trial name
- NCT00917644
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Glaucoma
Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured…
- Trial name
- NCT02512042
- Testing
- Test-Brinzolamide 1% Ophthalmic suspension, Reference-Brinzolamide 1% Ophthalmic suspension
- Where
- 10 sites in United States
- Volunteers
- 973 people
- Sponsor
- Actavis Inc.
Bioequivalence Study in Healthy Subjects, PK/PD
Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone).
- Trial name
- NCT07015671
- Testing
- 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet, FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Healthy
A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets…
- Trial name
- NCT01508182
- Testing
- Canagliflozin tablets, Metformin IR tablets, Canagliflozin/metformin IR FDC tablets
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence of Telmisartan Film-coated Tablet Compared With the Conventional Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers
Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the conventional 40 mg telmisartan tablet
- Trial name
- NCT02263989
- Testing
- Telmisartan film coated tablet, Telmisartan conventional tablet
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Breast Cancer, Breast Neoplasms
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Trial name
- NCT06886659
- Testing
- Trastuzumab (proposed Trastuzumab biosimilar), Herclon
- Where
- 2 sites in Bangladesh
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Incepta Pharmaceuticals Ltd
Healthy Subjects
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233162
- Testing
- Febuxostat-Test product, Febuxostat-Reference product
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
A Study Comparing Four Different Rivoceranib Tablets in Healthy Participants
The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets in healthy adult participants.
- Trial name
- NCT05287360
- Testing
- Rivoceranib
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Elevar Therapeutics
Healthy
Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited under fed conditions.
- Trial name
- NCT01149980
- Testing
- Citalopram Hydrobromide
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Relative Bioavailability Study of Alprazolam 3 mg ER Tablets Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia \& Upjohn Company following a single oral dose (1 x 3…
- Trial name
- NCT00865761
- Testing
- Alprazolam 3 mg Extended Release Tablets, single dose, XANAX XR® 3 mg tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered…
- Trial name
- NCT00647881
- Testing
- Paroxetine Hydrochloride Controlled-Release Tablets 25 mg, Paxil CR™ Tablets 25 mg
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
- Trial name
- NCT05363592
- Testing
- CT-L01 12.5/500 mg, Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited under fasting conditions.
- Trial name
- NCT01149967
- Testing
- Citalopram Hydrobromide
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Allergic Asthma
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and…
- Trial name
- NCT06494345
- Testing
- Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Xolair®, solution for subcutaneous administration, 150 mg
- Where
- Russia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Healthy
Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects
The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules (test product) and co-codamol 30mg/500mg tablets (reference product).
- Trial name
- NCT03280095
- Testing
- co-codamol 15mg/500mg capsule, co-codamol 30mg/500mg tablet
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Galen Limited
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