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

NCT05438316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-06-29

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 (Tritace®, 10 mg tablets) or the test (Ramipril, 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

Ramipril tablet 10 mg

Ramipril is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of ramipril.

DRUG

Tritace® tablet 10 mg

Tritace® is manufactured by Sanofi-Aventis Deutschland GmbH, Germany. Each tablet contains 10 mg of ramipril.

Sponsors & Collaborators

  • Ligand Research, LLC

    collaborator NETWORK

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Sergey Filatov · Ligand Research, LLC

  • Irina Rodiukova · 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
2022-06-17
Primary Completion
2022-08-02
Completion
2022-11-17

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 NCT05438316 on ClinicalTrials.gov