Clinical trials: Therapeutic Equivalency
Bioequivalency
Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.
The proposed study was designed as a randomized two-sequence, two period crossover trial to assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7.5 mg] vs.
- Trial name
- NCT01229280
- Testing
- Darifenacin
- Where
- Uruguay
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Center for Clinical Pharmacology Research Bdbeq S.A.
Hypogonadism
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and…
- Trial name
- NCT07097259
- Testing
- Test: Follitropin alfa, Reference: Follitropin alfa, Zoladex
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Healthy
Leflunomide 20 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc.
- Trial name
- NCT00834418
- Testing
- Leflunomide 20 mg Tablets, ARAVA™ 20 mg Tablets
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Ivermectin From Revemact 6 mg Tablets (Man. by EVA Pharma for Horus for Pharmaceutical Industries, Egypt) and Stromectol 2*3 mg Tablets (Merck Sharp & Dohme B.V., Haarlem, The Netherlands)
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Ivermectin from Revemact 6 mg tablets (Man.
- Trial name
- NCT04854460
- Testing
- Revemact, Stromectol (first dose), Stromectol (second dose)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
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
Acne
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
- Trial name
- NCT01135069
- Testing
- Tretinoin microsphere 0.1%, Brand Retin-A Micro tretinoin microsphere gel 0.1%
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Spear Pharmaceuticals
Bacterial Infection
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Trial name
- NCT00939562
- Testing
- doxycycline monohydrate tablet, doxycycline carragenate tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Heart Failure
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
Primary objective is to is to evaluate the bioequivalence of two formulations
- Trial name
- NCT06266988
- Testing
- Sacubitril and Valsartan Tablets 97mg/103mg, Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Viatris Inc.
Schizophrenia
Bioequivalence Fasting Study in Patients
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg.
- Trial name
- NCT02072954
- Testing
- Asenapine Sublingual Tablets 10 mg
- Where
- 2 sites in India
- Volunteers
- 48 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Bioequivalence Study of Budesonide/Formoterol Inhalation Powder in Healthy Participants
The goal of this study is to learn if a new formulation of Budesonide/Formoterol Inhalation Powder (160μg/4.5μg), manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd., works the same as the already approved reference…
- Trial name
- BF-BE (NCT07804303)
- Testing
- Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test), Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
Healthy
A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir hydrochloride tablets 1 gram manufactured by OHM…
- Trial name
- NCT01222910
- Testing
- Valacyclovir hydrochloride
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
T2D
Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
- Trial name
- NCT07670897
- Testing
- GZR4 injection A, GZR4 injection B
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Asthma
Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions
- Trial name
- NCT01659918
- Testing
- Montelukast, Singulair
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bioequivalence
Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT05982990
- Testing
- Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals, ADVAIR DISKUS® 250/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Hypertension
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components
This study will be a randomized study investigating the bioequivalence of COREG CR and Lisinopril to COREG CR and ZESTRIL
- Trial name
- NCT00556920
- Testing
- COREG CR
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.
- Trial name
- NCT00803218
- Testing
- Fluticasone Propionate 0.005% Ointment-Reference Product, Fluticasone Propionate 0.005% Ointment-Test product
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Bioequivalence
Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions
This is a phase I, single-center, open-label, randomized, two-period, two-way crossover, single-dose bioequivalence study in which the active substance ivermectin is administered as a single dose of 12 mg as either CHILD-IVITAB…
- Trial name
- CHILD-IVITAB (NCT05477810)
- Testing
- Treatment A (investigational drug) followed by Treatment B (reference drug), Treatment B (reference drug) followed by Treatment A (investigational drug)
- Where
- Switzerland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University Children's Hospital Basel
Healthy
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions
The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc.
- Trial name
- NCT00829790
- Testing
- Doxycycline Monohydrate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions
Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT
- Trial name
- NCT00659074
- Testing
- Ondansetron, Zofran
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy Volunteer
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
This four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Copegus tablet in healthy adult volunteers.
- Trial name
- NCT01697436
- Testing
- ribavirin [Copegus]
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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