Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril Erbumine/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg Tablets (Pharmtechnology LLC, Republic of Belarus) and Triplixam® 10 mg/2.5 mg/10 mg Tablets (Les Laboratoires Servier Industrie, France) in Healthy Volunteers Under Fasting Conditions

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 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.

Start Date24 Jun 2023

Sponsor / Collaborator

Pharmtechnology, LLC

EUCTR2020-004891-16-HR / Not yet recruitingPhase 3IIT

Evaluation of the clinical efficacy and safety of perindopril 10 mg/indapamide 2.5 mg/amlodipine 5 or 10 mg/bisoprolol 5 mg in single-pill combination after 8 weeks of treatment versus the free combination of perindopril 10 mg, indapamide 2.5 mg and amlodipine 5 or 10 mg in patients with uncontrolled essential hypertension. An international, multicentre, randomised, double-blind, 16-week study.

Start Date01 Mar 2023

Sponsor / Collaborator

Institut de Recherches Intern Servier

NCT05470764 / CompletedPhase 1

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® TRIO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide/ 10 mg Amlodipine Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") And Reference 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 Subjects Under Fasting Conditions

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.

Start Date30 May 2021

Sponsor / Collaborator

Darnitsa Pharmaceutical Co.

[+1]

100 Clinical Results associated with Perindopril Erbumine/Indapamide/Amlodipine

100 Translational Medicine associated with Perindopril Erbumine/Indapamide/Amlodipine

100 Patents (Medical) associated with Perindopril Erbumine/Indapamide/Amlodipine

100 Deals associated with Perindopril Erbumine/Indapamide/Amlodipine

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 2	JO	Darnitsa Pharmaceutical Co.	30 May 2021
Essential Hypertension	Phase 2	CN	Institut de Recherches Intern Servier	06 May 2019

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