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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
PT Equilab International
Jakarta, Jakarta Special Capital Region, Indonesia
AUCt
Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Time frame: 36 hours
AUCinf
Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Time frame: 36 hours
Cmax
The peak plasma concentration of the drug was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Time frame: 36 hours
Tmax
The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Time frame: 36 hours
T1/2
The elimination half life was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Time frame: 36 hours
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