MedTrace Logo

Bioequivalence Study of Perindopril /Amlodipine/Indapamide 8 mg (10 mg)/2.5 mg/10 mg Tablets in Healthy Volunteers Under Fasting Conditions

NCT05940909 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-11

No results posted yet for this study

Summary

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.

Conditions

  • Bioequivalence

Interventions

DRUG

Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet

Perindopril/Indapamide/Amlodipine is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 8 mg of perindopril erbumine, 2.5 mg of indapamide and 10 mg of amlodipine. Triplixam® is manufactured by Les Laboratoires Servier Industrie, France. Each tablet contains 10 mg of perindopril arginine, 2.5 mg of indapamide and 10 mg of amlodipine.

Sponsors & Collaborators

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Irina Rodyukova · Ligand Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-24
Primary Completion
2023-08-17
Completion
2023-11-17

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05940909 on ClinicalTrials.gov