Clinical trials: Bioequivalence
Healthy
A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from Soviredia 90/400 mg Tablets (Minapharm…
- Trial name
- NCT04039958
- Testing
- Soviredia, Harvoni (first dose), Harvoni (Second dose)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and…
- Trial name
- NCT00840099
- Testing
- 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL, Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Gouty Arthritis (GA)
A Bioequivalence Study of Two Different Dosage Form of Genakumab
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
- Trial name
- NCT06451848
- Testing
- Genakumab Injection (T, Solution for injection), Genakumab for Injection (R, Powder for solution for injection)
- Where
- China
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy
Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under fasting conditions.
- Trial name
- NCT00776334
- Testing
- Fosinopril 40mg Tablets
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Seasonal Allergic Rhinitis
Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™
To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of…
- Trial name
- NCT02249663
- Testing
- Azelastine hydrochloride and Fluticasone propionate, Dymista™
- Where
- United States
- Volunteers
- 1,535 people
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.
- Trial name
- NCT01226693
- Testing
- PH-797804 material sparing tablet, PH-797804 Phase2b/3 with sodium lauryl sulphate, PH-797804 Phase2b/3 without sodium lauryl sulphate
- Where
- Singapore
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subjects
Bioequivalence Study of Different Aprocitentan Tablet Formulations
The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.
- Trial name
- NCT05196399
- Testing
- Aprocitentan (Formulation A), Aprocitentan (Formulation B)
- Where
- Czechia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy
A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy volunteers.
- Trial name
- NCT05568121
- Testing
- L04RD1, L04TD1
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Celltrion
Diabetes, Healthy
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.
- Trial name
- NCT01490099
- Testing
- insulin detemir
- Where
- United Kingdom
- Volunteers
- 37 people
- Sponsor
- Novo Nordisk A/S
Healthy
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
- Trial name
- NCT01627847
- Testing
- Ropinirole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Benazepril HCl 40 mg Tablets, Fed
This study will compare the relative bioavailability (rate and extent of absorption) of 40 mg Benazepril Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd.
- Trial name
- NCT00836537
- Testing
- Benazepril HCl 40 mg Tablets, Lotensin® 40 mg Tablets
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Type 2 Diabetes
Bioequivalence Study to Compare Imeglimin HCl 500 mg Film Coated Tablets Versus Twymeeg Tablets 500 mg
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of Imeglimin HCl 500 mg Film Coated Tablets of Humanis Sağlık A.Ş., Ç.O.S.B.
- Trial name
- NCT07691177
- Testing
- Imeglimin Hydrochloride Film Coated Tablet, TWYMEEG® Tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Diabetes Mellitus
A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin.
- Trial name
- NCT01476345
- Testing
- LY2963016, Lantus
- Where
- South Africa
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana [IN]) to coadministered 5 mg…
- Trial name
- NCT01192139
- Testing
- saxagliptin, metformin XR, saxagliptin + metformin XR (FDC tablet)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
Kidney Diseases, Kidney Injury
A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants
Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102…
- Conditions
- Kidney Diseases, Kidney Injury, Kidney Failure
- Trial name
- NCT05943977
- Testing
- MB-102 DMID, MB-102 OMID, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 2 sites in China
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Fasting
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study.
- Trial name
- NCT01827865
- Testing
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together
Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin…
- Trial name
- NCT01811953
- Testing
- Empagliflozin, Metformin, Empagliflozin/Metformin
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
The purpose of this study is to determine whether Transtec (R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after single dose application
- Trial name
- NCT00388219
- Testing
- Transtec (R) PRO (buprenorphine)
- Where
- 2 sites in Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH