NCT02233777

Bioequivalence Study of Two Formulations of Pregabalin Capsules 150 mg

Bioequivalence Study of 150 mg Pregabalin Capsules Produced by PT Dexa Medica in Comparison With the Comparator Product (Lyrica® Capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study was conducted to find out whether the bioavailability of 150 mg pregabalin capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).

Detailed description

This was a randomized, open label, two-period, two-sequence, crossover study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one capsule of the test drug (Pregabalin 150 mg produced by Dexa Medica) or one capsule of the reference drug (Lyrica® 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany). Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug. The plasma concentrations of pregabalin were determined by using validated liquid chromatography with tandem mass spectrometry detection (LC-MS/MS) method.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin capsules 150 mg of Dexa Medica	Each capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
DRUG	Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland	Each capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-09-08
• Last updated: 2014-09-08

Locations

1 site across 1 country: Indonesia