CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Perindopril 4 mg tablets of PT Dexa Medica +1 moredrug
Likely dose
Perindopril 4 mg tablets of PT Dexa Medicafrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01682577
NCT01682577N/ACompleted
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Bioequivalence Study of 4 mg Perindopril Tablets Produced by PT Dexa Medica in Comparison With the Reference Tablets (Prexum® 4 mg, Servier)Under Fasting Condition

Dexa Medica Group·interventional·Posted Sep 11, 2012·Updated Sep 11, 2012

In Brief

A clinical study evaluating Perindopril 4 mg tablets of PT Dexa Medica and Perindopril 4 mg tablets of Servier for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2012
Enrollment StartSep 1, 2008
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.8 years ago

Interventions

Perindopril 4 mg tablets of PT Dexa Medicadrug

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

Perindopril 4 mg tablets of Servierdrug

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