Clinical trials: Therapeutic Equivalency
Healthy
A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.
- Trial name
- NCT07128654
- Testing
- CTL02, CTL0201, CTL0202
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
Famciclovir 500 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions.
- Trial name
- NCT00834431
- Testing
- Famciclovir 500 mg Tablets, Famvir® 500 mg Tablets
- Where
- 2 sites in United States, Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets) in healthy subjects under…
- Trial name
- NCT00834990
- Testing
- divalproex sodium, Depakote®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Subjects
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm).
- Trial name
- NCT02279485
- Testing
- Perampanel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers, Diabetes Mellitus, Type 2
A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens
The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions.
- Trial name
- NCT04152915
- Testing
- Semaglutide
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants
The purpose of this study to evaluate the bioequivalence (is the amount same in both the pills) of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with…
- Trial name
- NCT02220218
- Testing
- Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC), Canagliflozin, Metformin IR
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence Study of Torrent Pharmaceutical Limited's ISMN 120 mg ER Tablets Under Fasting Condition
Objective: to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA.
- Trial name
- NCT01418534
- Testing
- Torrent's Isosorbide Mononitrate 120 mg ER Tablets
- Where
- 2 sites in India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)
The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administration under fasting conditions.
- Trial name
- NCT00983996
- Testing
- Alendronate Sodium Tablets, 10 mg, Fosamax Tablets, 10 mg
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Hereditary Tyrosinemia, Type I
Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin
The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1 (TP1)) and Nitisinone 10 mg Tablets High Compritol (Test Product 2 (TP2)) are bioequivalent to the reference product Orfadin 10 mg…
- Trial name
- NCT02750709
- Testing
- Nitisinone, Nitisinone 10 mg Tablet High Compritol, Orfadin
- Where
- South Africa
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Fasting
A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer…
- Trial name
- NCT01602055
- Testing
- Azithromycin
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT Novell Pharmaceutical Laboratories
Bioequivalence
A Study Comparing Oxymetazoline 1% Cream to RHOFADE
randomized, double-blind, placebo controlled
- Trial name
- NCT05148689
- Testing
- Oxymetazoline hydrochloride Cream, 1%, Rhofade™ (oxymetazoline) cream, 1%
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Healthy
Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg
The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 30 mg tablet (manufactured for First Horizon) following…
- Trial name
- NCT00985660
- Testing
- Nisoldipine Extended-release Tablets, 30 mg, Sular® Extended Release Tablets, 30 mg
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Study Comparing Two Different Tablet Formulations Of Bosutinib
This study is comparing 2 formulations of bosutinib in healthy subjects.
- Trial name
- NCT00934674
- Testing
- SKI-606 (Bosutinib)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy Adult Male and Female Volunteers
A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:
The purpose of this study is to evaluate the bioavailability, safety and tolerability of Torasemide 10 mg tablets (Berlin-Chemie AG), compared to Unat® 10 tablets (Viatris Healthcare GmbH) in healthy adult participants under…
- Trial name
- NCT07201584
- Testing
- Torasemide tablet 10 mg, Unat® 10 tablets (Torasemide 10 mg)
- Where
- Kazakhstan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Herpes Labialis
Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects
- Trial name
- NCT00711776
- Testing
- New formulation, Current formulation
- Where
- Japan
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01511718
- Testing
- Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
HIV Infections
A Study Comparing Two Forms of Didanosine in HIV-infected Patients
The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe and absorbed by the body as well as the chewable-tablet form of ddI. Didanosine (ddI) is an anti-HIV drug.
- Trial name
- NCT00002360
- Testing
- Didanosine
- Volunteers
- 30 people
- Sponsor
- Bristol-Myers Squibb
Healthy
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects
Objective: A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available…
- Trial name
- NCT00944346
- Testing
- Metformin HCl
- Where
- United States
- Sponsor
- Torrent Pharmaceuticals Limited
Contraception
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)
The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body…
- Trial name
- NCT01253187
- Testing
- EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300), EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca), L-5-MTHF 0.451mg (Metafolin)
- Where
- Netherlands
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Bayer
Hypertension
A Bioequivalence and Safety Study of AJU-C719 and C719R in Healthy Adult Volunteers
To evaluate the bioequivalence and safety of "AJU-C719" and "C719R" in healthy adult subjects.
- Trial name
- NCT07901114
- Testing
- Test Drug, Reference Drug
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AJU Pharm Co., Ltd.
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