MedTrace Logo

Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition

NCT01682577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-09-11

No results posted yet for this study

Summary

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).

Conditions

  • Healthy

Interventions

DRUG

Perindopril 4 mg tablets of PT Dexa Medica

Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

DRUG

Perindopril 4 mg tablets of Servier

Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Danang A Yunaidi, MD · PT Equilab International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • Indonesia

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 NCT01682577 on ClinicalTrials.gov