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

NCT05685277 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-08

No results posted yet for this study

Summary

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.

Conditions

  • Bioequivalence

Interventions

DRUG

Ramipril/Hydrochlorothiazide tablet 10 mg/25 mg

Ramipril/Hydrochlorothiazide is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of ramipril and 25 mg of hydrochlorothiazide.

DRUG

Tritace® Plus tablet 10 mg/25 mg

Tritace® Plus is manufactured by Sanofi S.p.A., Italy (holder of the registration certificate: Sanofi-Aventis Deutschland GmbH, Germany). Each tablet contains 10 mg of ramipril and 25 mg of hydrochlorothiazide.

Sponsors & Collaborators

  • Ligand Research, LLC

    collaborator NETWORK

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Sergey Filatov · Ligand Research, LLC

  • 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
2022-12-28
Primary Completion
2023-02-22
Completion
2023-07-31

Countries

  • Russia

Study Locations

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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 NCT05685277 on ClinicalTrials.gov