Overview

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

Status:
Not yet recruiting

Trial end date:
2023-05-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborator:

Ligand Research, LLC

Treatments:

Hydrochlorothiazide
Ramipril