NCT01682577

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed description

The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Perindopril 4 mg tablets of PT Dexa Medica) or one tablet of the reference drug (Prexum® 4 mg, Servier). Blood samples were drawn immediately before taking the drug (control), and at 20, 40 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 192 hours after drug administration. Three weeks after the first drug administration (washout period), the procedure was repeated using the alternate drug. The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were determined based on the concentrations of the perindopril parent compound and the metabolite perindoprilat, using high-performance liquid chromatography method with tandem mass spectrometry detector (LC-MS/MS).

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2012-09-11
• Last updated: 2012-09-11

Locations

1 site across 1 country: Indonesia