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Bioequivalence clinical trials

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NCT ID: NCT05685277 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under Fasting Conditions

Start date: December 28, 2022
Phase: Phase 1
Study type: Interventional

This is an open-labeled, with blinding bioanalytical stage, randomized, two period, two sequences, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace® Plus, 10 mg/25 mg tablets) or the test (Ramipril/Hydrochlorothiazide, 10 mg/25 mg tablets) 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: NCT05663398 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers

Start date: May 17, 2022
Phase: Phase 1
Study type: Interventional

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Darfen 400, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and Reference medicinal product (marketed medicinal product Nurofen® Forte Express, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by Reckitt Benckiser [Poland] S.A.) in healthy volunteers.

NCT ID: NCT05663372 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers

Start date: December 7, 2021
Phase: Phase 1
Study type: Interventional

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa", Ukraine) and Reference medicinal product (marketed medicinal product INSPRA® 50 mg eplerenone film-coated tablets, Marketing Authorisation Holder: Pfizer Europe MA EEIG, Belgium) in healthy volunteers.

NCT ID: NCT05642845 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Atorvastatin Film-coated Tablets 40 mg in Healthy Volunteers Under Fasting Conditions

Start date: November 19, 2022
Phase: Phase 1
Study type: Interventional

This is an open-labeled, randomized, two period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Liprimar®, 40 mg film-coated tablets) or the test (Atorvastatin, 40 mg film-coated tablets) 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: NCT05549583 Completed - Type 2 Diabetes Clinical Trials

Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers

Start date: April 15, 2018
Phase: Phase 1
Study type: Interventional

The objective of this study was to determine the bioequivalence of two different formulations of sitagliptin/ metformin after a single oral dose administration under fed conditions.

NCT ID: NCT05549570 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers

Start date: October 22, 2017
Phase: Phase 1
Study type: Interventional

The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed conditions.

NCT ID: NCT05519514 Completed - Healthy Subjects Clinical Trials

Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects

Start date: July 12, 2021
Phase: Phase 1
Study type: Interventional

A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition.

NCT ID: NCT05477810 Completed - Bioequivalence Clinical Trials

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

CHILD-IVITAB
Start date: September 13, 2022
Phase: Early Phase 1
Study type: Interventional

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 or STROMECTOL during two study drug administration periods. Each treatment will be investigated in the same subgroup of 16 healthy male or female study participants under fasted conditions.

NCT ID: NCT05470764 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide / 10 mg Amlodipine Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets in Healthy Volunteers

Start date: May 30, 2021
Phase: Phase 1
Study type: Interventional

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy adult volunteers under fasting conditions.

NCT ID: NCT05464745 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of 8 mg Perindopril Tert-butylamine / 2.5 mg Indapamide Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-coated Tablets in Healthy Volunteers

Start date: May 19, 2021
Phase: Phase 1
Study type: Interventional

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Noliterax® 10 mg /2.5 mg, 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy volunteers.