Clinical trials: Therapeutic Equivalency
Chronic Obstructive Pulmonary Disease
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).
- Trial name
- NCT03137992
- Testing
- Test Product (tiotropium bromide inhalation powder), Reference Product (Spiriva®)
- Where
- 34 sites in United States
- Volunteers
- 377 people
- Sponsor
- Lupin, Inc.
Healthy, Pharmacokintetics
Bioequivalence Study of Levomerc 500 mg Tablets
An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy…
- Trial name
- BABE (NCT05339295)
- Testing
- Levofloxacin 500mg
- Where
- Pakistan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Karachi
Healthy
Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of moexipril HCl/ hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets…
- Trial name
- NCT00834067
- Testing
- Moexipril HCl/hydrochlorothiazide 15/25 mg tablets, UNIRETIC® 15/25 mg tablets
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Topiramate 25 mg Tablets Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.
- Trial name
- NCT00905567
- Testing
- Topiramate 2 x 25 mg tablet, Topamax® Tablet 2 x 25 mg
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.
The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination…
- Trial name
- NCT02395237
- Testing
- : Amaryl® M IR 2/1000
- Where
- Jordan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pharmaceutical Research Unit, Jordan
Healthy
Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.
- Trial name
- NCT00803439
- Testing
- Clobetasol Propionate 0.05% Foam-Reference Product, Clobetasol Propionate 0.05% Foam-Test product
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Healthy
Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg-42.9 mg/ 5 mL Oral Suspension Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Ranbaxy Laboratories Limited, India, Amoxicillin-Clavulanic acid and GlaxoSmithKline, U.S.A.
- Trial name
- NCT00778544
- Testing
- amoxicillin-clavulanic acid 600 mg- 42.9 mg/ 5 mL oral suspension
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Type 1 Diabetes
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
Primary Objective: To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose…
- Trial name
- NCT03903016
- Testing
- Insulin Lispro SAR342434
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Sanofi
Healthy Subjects
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
A study comparing 2 different investigational formulations of pantoprazole in healthy adults.
- Trial name
- NCT00383916
- Testing
- pantoprazole
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions
To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT
- Trial name
- NCT00654277
- Testing
- Ondansetron, Zofran
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Thrombocytopenia
Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fasting conditions.
- Trial name
- NCT06768632
- Testing
- Group 1: single-dose of test formulation+single-dose of reference formulation, Group 2: single-dose of reference formulation+single-dose of test formulation
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.
- Trial name
- NCT00649532
- Testing
- Ondansetron Tablets 24 mg, Zofran® Tablets 24 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially…
- Trial name
- NCT00834795
- Testing
- Carvedilol 25 mg tablets, COREG® 25 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Human Volunteers
A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers
The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.
- Trial name
- NCT01618877
- Testing
- Levetiracetam
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Healthy Volunteer
A Study to Compare Blood Levels of Different Dosage Formulations of the Study Medicine That Is a CGRP Receptor Antagonist in Healthy Adults
The purpose of this study is to assess the bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of different formulations of a CGRP receptor antagonist in…
- Trial name
- NCT07261371
- Testing
- Test formulation (Treatment A), Reference formulation (Treatment B), Test formulation (Treatment C)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, Ovarian Cancer
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection (Lipodox®) in Chinese Patients
Bioequivalence study is proposed to be carried out on patients of breast cancer/ ovarian cancer, who are administrated for Doxorubicin Hydrochloride Liposomal Injection Lipodox® or Caelyx® in a dose of 50 mg/m2.
- Trial name
- NCT05273944
- Testing
- Doxorubicin Hydrochloride Liposome Injection
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Healthy Subjects
Sildenafil 100 mg Tablets Relative to Viagra 100 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
- NCT06289881
- Testing
- Sildenafill-Test product, Sildenafill-Reference product
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed 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 fed…
- Trial name
- NCT01131767
- Testing
- Naproxen Sodium & Pseudoephedrine HCl
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Pharmacokinetics, Therapeutic Equivalency
Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
- Conditions
- Pharmacokinetics, Therapeutic Equivalency, Contraceptives, Oral
- Trial name
- NCT00709644
- Testing
- Norgestimate; Ethinyl Estradiol; Folic acid.
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Bioequivalence Study of Lu AF35700
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
- Trial name
- NCT03394482
- Testing
- Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
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