title: A Comparative Pharmacokinetics Study of the Anti-Parkinsonian Drug Pramipexole.
abstract: The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 healthy volunteers. One of the 0.25 mg formulations of pramipexole evaluated in the study was manufactured by PT Dexa Medica, Palembang, Indonesia, the other, used as the reference, by Boehringer Ingelheim Pharma GmbH &amp; Co. KG, Ingelheim am Rhein, Germany. All eligible subjects were required to fast before each drug administration period, which was separated by a one-week washout period. Pramipexole concentrations in plasma were assayed using a validated ultra performance liquid chromatography with mass spectrometry (UPLC-MS/MS) detector. The evaluated pharmacokinetic parameters included the area under the plasma concentration curve from time zero to the last observed measurable concentration (AUC0-t), the area under the plasma concentration curve extrapolated to infinite time (AUC0-∞), the maximum plasma concentration (Cmax), the time to reach Cmax(tmax), and the plasma concentration half-life (t1/2). To evaluate the bioequivalence of those two pramipexole formulations, 90% confidence intervals (CIs) for geometric mean ratios of both formulations were calculated for AUC and Cmaxparameters, while tmaxand t1/2differences were analyzed on the non-transformed data using Wilcoxon matched-pairs and a Student's pairedt-test, respectively. The 90% CIs for the geometric mean ratios of the two pramipexole formulations were 95.89% (90.73%-101.34%), 95.53% (89.75%-101.68%), and 92.11% (84.35%-100.58%) for AUC0-t, AUC0-∞, and Cmax, respectively. There were no statistically significant differences for tmaxand t1/2between the two pramipexole formulations. It is concluded that two pramipexole formulations in this study were bioequivalent.
authors.affiliation: PT Equilab International Bioavailability and Bioequivalence Laboratory, Jl. RS Fatmawati Persil 33, 12430 Jakarta, Indonesia. ratih@equilab-int.com.
authors.forename: Ratih S I
authors.initials: RS
authors.lastname: Putri
authors.affiliation: PT Equilab International Bioavailability and Bioequivalence Laboratory, Jl. RS Fatmawati Persil 33, 12430 Jakarta, Indonesia. effi@equilab-int.com.
authors.forename: Effi
authors.initials: E
authors.lastname: Setiawati
authors.affiliation: PT Equilab International Bioavailability and Bioequivalence Laboratory, Jl. RS Fatmawati Persil 33, 12430 Jakarta, Indonesia. syifa.aziswan@equilab-int.com.
authors.forename: Syifa A
authors.initials: SA
authors.lastname: Aziswan
authors.affiliation: Dexa Laboratories of Biomolecular Sciences (DLBS), Industri Selatan V Block PP No. 7, Jababeka Industrial Estate II, Cikarang, 17550 West Java, Indonesia. fenny@dexa-medica.com.
authors.forename: Fenny
authors.initials: F
authors.lastname: Ong
authors.affiliation: Dexa Laboratories of Biomolecular Sciences (DLBS), Industri Selatan V Block PP No. 7, Jababeka Industrial Estate II, Cikarang, 17550 West Java, Indonesia. raymond@dexa-medica.com.
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Tjandrawinata
authors.affiliation: Dexa Laboratories of Biomolecular Sciences (DLBS), Industri Selatan V Block PP No. 7, Jababeka Industrial Estate II, Cikarang, 17550 West Java, Indonesia. fenny@dexa-medica.com.
authors.forename: Liana W
authors.initials: LW
authors.lastname: Susanto
keywords: Parkinson’s disease; bioavailability; bioequivalence; pharmacokinetics; pramipexole