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Bioequivalence clinical trials

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NCT ID: NCT05160090 Completed - Bioequivalence Clinical Trials

Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg

Start date: January 18, 2020
Phase: Phase 1
Study type: Interventional

The objective of this study is to determine the bioequivalence of 2 different formulations of bupropion after a single oral dose administration under fasting conditions. The secondary objective of this study is to evaluate the safety and tolerability of the Test and Reference formulations in healthy subjects.

NCT ID: NCT05158192 Completed - Bioequivalence Clinical Trials

Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product

Start date: November 4, 2021
Phase: Phase 1
Study type: Interventional

This Pilot study investigated the bioavailability in adult human subjects of 1 tablet formulations containing Diosmin/Hesperidin (90/10) 500 mg. The Pilot study was performed at a single site with 12 subjects. Participants took 1 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There was a washout of 7 days between each study period.

NCT ID: NCT05148689 Completed - Bioequivalence Clinical Trials

A Study Comparing Oxymetazoline 1% Cream to RHOFADE

Start date: February 23, 2018
Phase: Phase 1
Study type: Interventional

randomized, double-blind, placebo controlled

NCT ID: NCT05145621 Completed - Safety Clinical Trials

Oral Bio-equivalence Study

Start date: October 29, 2015
Phase: Phase 1
Study type: Interventional

Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions. Objective: The objective of this study is to compare the oral bioavailability and characterize the pharmacokinetic profile of the test formulation relative to that of reference formulation in healthy, adult, human subjects under fasting conditions and to assess the bioequivalence.

NCT ID: NCT05145608 Completed - Bioequivalence Clinical Trials

Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

Start date: January 10, 2018
Phase: Phase 1
Study type: Interventional

Objective: To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions. The secondary objective is to monitor the safety of the subjects.

NCT ID: NCT05083325 Completed - Bioequivalence Clinical Trials

Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product

Start date: October 8, 2021
Phase: Phase 1
Study type: Interventional

This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 capsule formulation containing Oseltamivir Phosphate 75 mg. The study will be performed at a single site with 36 subjects. Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.

NCT ID: NCT05076474 Completed - Bioequivalence Clinical Trials

Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The study will start with a run-in period with controlled diet and no drug for 5 consecutive days. This is to accustom the subjects to the standardized diet and also to determine baseline fecal fat excretion. After run-in period, subjects will be randomized to receive either test or reference orlistat formulations (60 mg or 120 mg) thrice daily under fed conditions for 10 consecutive days.

NCT ID: NCT05061901 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions

Start date: October 6, 2021
Phase: Phase 1
Study type: Interventional

This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Zestril®, 20 mg) or the test (Lisinopril, 20 mg) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent

NCT ID: NCT05055752 Completed - Bioequivalence Clinical Trials

Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.

Start date: May 7, 2020
Phase: Phase 1
Study type: Interventional

This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence study to determine PK parameters following treatment with test aspirin product (PL-ASA capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325 mg.

NCT ID: NCT05014490 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers

Start date: February 24, 2021
Phase: Phase 1
Study type: Interventional

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Arcoxia® 120 mg etoricoxib film-coated tablets, Marketing Authorisation Holder: UAB "Merck Sharp&Dohme", Lithuania) in healthy volunteers.