Clinical trials: Therapeutic Equivalency
Clinical Pharmacology
Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects
Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 10 mg in Japanese healthy…
- Trial name
- NCT04511611
- Testing
- Rivaroxaban (BAY 59-7939, Xarelto) in ODT form, Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
- Where
- 3 sites in Japan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Male Subjects
Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®
Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the same active content as Neupogen®. BK0023 is expected to have the same tolerability profile and clinical effects as Neupogen® in controlling…
- Trial name
- NCT01933971
- Testing
- Filgrastim test, Filgrastim reference
- Where
- Switzerland
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Bio-ker S.r.l.
Contraception
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
- Trial name
- NCT00620464
- Testing
- Radiopaque Implanon, Implanon (etonogestrel implant)
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Healthy
Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions
The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.
- Trial name
- NCT00805155
- Testing
- Mometasone Furoate 0.1% Topical Lotion-Reference Product, Mometasone Furoate 0.1% Topical Lotion-Test product 1, Mometasone Furoate 0.1% Topical Lotion-Test Product 2
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Sever Aplastic Anaemia
A Bioequivalence Study of Hetrombopag in Healthy Subjects
This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label…
- Trial name
- NCT05088655
- Testing
- Hetrombopag Olamine Tablet
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Schizophrenia
Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia.
The primary objective of this study is to evaluate the bioequivalence of aripiprazole for injection (Test product, 400 mg) compared with Abilify Maintena® (Reference product, 400 mg) at steady state in patients with…
- Trial name
- NCT07547384
- Testing
- Aripiprazole for Injection
- Volunteers
- 116 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Diabetes Mellitus
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.
The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of…
- Trial name
- NCT00596063
- Testing
- Wosulin R, Novolin R
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy, female subjects.
- Trial name
- NCT00800293
- Testing
- Betamethasone Dipropionate 0.05% Cream
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Bioequivalence, AUC, Cmax, Pharmacokinetics
Clopidogrel Bioequivalence Study in Healthy Subjects
This study will be an open-label, randomised, three-way crossover study in healthy male and female subjects, performed at a single centre.
- Trial name
- NCT02185534
- Testing
- Clopidogrel
- Where
- Germany
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Subjects
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets 40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were separated by a washout period of 7 days.
- Trial name
- NCT03319706
- Testing
- Torrent's Olmesartan Medoxomil Tablets 40 mg, Daiichi Sankyo Inc's Benicar Tablets 40 mg
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Bioequivalence
The Bioequivalence Study of Two Sunitinib Products in Capsules 50 mg in Healthy Volunteers Under Fasting Conditions
The study is designed in accordance with the Eurasian Economic Union (EAEU) regulatory guidelines, with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers.
- Trial name
- NCT05218616
- Testing
- Aviga, capsules 50 mg / Sutent®, capsules 50 mg, Sutent®, capsules 50 mg / Aviga, capsules 50 mg
- Where
- Belarus
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- JLLC NatiVita
Healthy
Bioequivalence Study of Tizanidine HCl 4mg Tablets of Dr.Reddy's Under Fed Conditions
The purpose of this bioequivalence study is to compare the test tizanidine Hydrochloride 4mg tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in healthy adult subjects under fed conditions.
- Trial name
- NCT01065987
- Testing
- Tizanidine
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Parenteral Nutrition
A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)
This is a phase 1, prospective, single-center, randomized sequence, double-blind, 2-way crossover, relative bioavailability study in healthy adult subjects comparing Sodium Glycerophosphate Injection (SGP) to Sodium Phosphate…
- Trial name
- NCT06842121
- Testing
- Sodium Glycerophosphate Injection, Sodium Phosphates Injection
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Diabetes, Healthy
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process
This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.
- Trial name
- NCT01486914
- Testing
- insulin aspart
- Where
- United Kingdom
- Volunteers
- 28 people
- Sponsor
- Novo Nordisk A/S
Bioequivalence
A Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT03820180
- Testing
- Test Product, Reference Product
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
no Condition
Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)
Study primary Objective: To evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of N-acetyl-cysteine 600 mg uncoated tablets vs.
- Trial name
- NCT02265224
- Testing
- N-acetylcysteine
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Zambon SpA
Healthy
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in…
- Trial name
- NCT02296723
- Testing
- Valganciclovir Hydrochloride
- Where
- India
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Hypertension
A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323
This study is required to confirm the suitability of a candidate FDC of 16mg candesartan cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to allow the design of a future pivotal…
- Trial name
- NCT02094924
- Testing
- GSK587323, FDC of candesartan cilexetil 16 mg and HCTZ 12.5mg
- Where
- India
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fasting Conditions
The purpose of this study to compare the rate and extent of absorption of Actavis Group hf, Iceland, finasteride and Merck \& Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1 x 5 mg tablet, under fasting conditions.
- Trial name
- NCT00870480
- Testing
- Finasteride 5 mg Tablet, single dose, Proscar® 5 mg Tablet, single dose
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy Volunteer
Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting condition.
- Trial name
- NCT03214159
- Testing
- Ritonavir Tablet 100mg, NORVIR tablet 100mg
- Where
- 2 sites in China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
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