Impact of Truncated Area on Point Estimate and Intra-Subject Variability in Bioequivalence of Dutasteride with Long Half-Life

Budi Prasaja, Yahdiana Harahap, Windy Lusthom, Lia Yumi, Anna Sofiana, Monica Sandra, Falah Safira, Uci Chilmi

Research output: Contribution to journalArticle

Abstract

Purpose To investigate the effect of using truncated area under the curve (AUC 0-72) on bioequivalence of dutasteride with long half-life in point estimate and intra-subject variability. Methods Fifteen subjects were enrolled in this single-dose, open-label, randomized two-way crossover design following an overnight fasting with five-week washout period. Plasma samples were collected to 72 h and 144 h following drug administration and dutasteride were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. The pharmacokinetic parameters for bioequivalence assessment were AUC 0-72 and AUC 0-144. Results The estimated point and the 90% confidence intervals were 91.07% (84.54-98.11%) for AUC 0-72 and 91.43% (84.65-98.75%) for AUC 0-144, that is, within the ranges for acceptance of bioequivalence. The intra-subject variability's were 11.45% for AUC 0-72 and 11.87% for AUC 0-144. Conclusions There was no statistically significant difference in point estimated and intra-subject variability between truncated AUC at 72 h and 144=h and the truncated AUC (AUC 0-72) approach could be considered for bioequivalence assessment for dutasteride.

Original languageEnglish
Pages (from-to)238-240
Number of pages3
JournalDrug Research
Volume68
Issue number4
DOIs
Publication statusPublished - 1 Apr 2018

Keywords

  • benign prostate hyperplasia
  • LC-MS/MS
  • pharmacokinetic

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