Bioequivalence Study of Low-Dose Anagrelide 0.5 mg Capsules under Fasting Conditions in Healthy Turkish Male Subjects
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The pharmacokinetic profiles and relative bioavailability of anagrelide from the test and reference preparations were compared to establish the test preparation's bioequivalence to the reference under fasting conditions. In a randomized sequence, male Caucasian subjects were administered a single dose of either one capsule of the test or reference preparation separated by a washout phase of seven days. Blood samples were collected at pre-specified time points following drug administration to assess anagrelide pharmacokinetics. These samples were collected in K 2 EDTA tubes, centrifuged, and stored at <-70°C. Anagrelide concentrations were quantified using a validated LC-MS/MS method with ESI(+). The pharmacokinetic parameters, including AUC (0−t) , AUC (0−∞) , C max , t max , λ z , t ½ (λ z ), and AUC %−extrapol , were calculated using Phoenix WinNonlin V8.1.0.3530 software. The absorption extent (AUC (0−t) ) and the absorption rate (C max ) of anagrelide from the test and reference preparations were found to be comparable. The 90% confidence intervals for the ln-transformed ratios of AUC (0−t) and C max of the test/reference preparations met the bioequivalence criteria of 80.00–125.00%. Furthermore, the 90% confidence interval for the ln-transformed data of the secondary pharmacokinetic parameter, AUC (0−∞) , of anagrelide was also included in the bioequivalence acceptance range.
