Healthy Clinical Trial
Official title:
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)
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).
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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