The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International 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 tablet of the test drug (Pramipexole 0.25 mg produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals) or one tablet of the reference drug (Sifrol® 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International 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, 8, 12, 16, 24, 36, and 48 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 pramipexole were determined by validated ultra performance liquid chromatography with mass spectrometry detector (UPLC-MS/MS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
23
Pramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug.
Pramipexole 0.25 tablets produced by Boehringer Ingelheim Pharma GmbH \& Co.KG for Boehringer Ingelheim International GmbH as the reference drug.
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 pramipexole from the test drug and reference drug.
Time frame: 48 hours
AUCinf
Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Time frame: 48 hours
Cmax
The peak plasma concentration of the drug was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Time frame: 48 hours
Tmax
The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Time frame: 48 hours
T1/2
The elimination half life was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Time frame: 48 hours
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