title: Pharmacokinetics and bioequivalence evaluation of two acipimox tablets: a single-dose, randomized-sequence, two-way crossover study in healthy Chinese male volunteers.
abstract: OBJECTIVE
  The study was designed to compare the pharmacokinetic parameters and relative bioavailability of a newly generic acipimox 250-mg tablets (test formulation) with a branded 250-mg tablets (reference formulation).
  
  
  METHODS
  A single-dose, randomized-sequence, 2-way crossover study was conducted in 20 healthy Chinese male volunteers in the fasted state. Plasma samples were collected over 12 h after a single oral dose of 250-mg acipimox test or reference, followed by a 7-day washout period. Plasma concentrations of acipimox were analyzed by high-performance liquid chromatography. Drug And Statistical-Version 2.0 was used to calculate the pharmacokinetic parameters and assess bioequivalence of the 2 formulations. It is considered bioequivalent if the 90% CIs of the mean ratios (test: reference) for Cmax, AUC0-t and AUC0-∞ are all within the range from 80% to 125%.
  
  
  RESULTS
  No period, formulation, or sequence effects were observed on any pharmacokinetic parameters. The main pharmacokinetic parameters for the test and reference were as follows: t1/2 were 1.412±0.168 h and 1.390±0.162 h; Tmax were 1.850±0.462 h and 1.800±0.571 h; Cmax were 4.035±1.055 μg · ml-1 and 3.858±0.986 μg · ml-1; AUC0-12 were 14.006±2.564 μg · ml-1 · h and 13.345±2.128 μg · ml-1 · h, and the AUC0-∞ were 14.147±2.568 μg · ml-1 · h and 13.486±2.117 μg · ml-1 · h. The 90% CIs for the ratios (test/reference) of Cmax, AUC0-12, and AUC0 - ∞ were 98.0-111.2%, 100.8-108.5%, and 100.8-108.3%, respectively.
  
  
  CONCLUSIONS
  In this small study, a single 250-mg oral dose of an acipimox tablet (test formulation) is bioequivalent to the established reference formulation.
authors: The Institute of Pharmacology, Medical Faculty of Shandong University, Jinan, China.
authors: J
authors: J
authors: Huang
authors: R
authors: R
authors: Chen
authors: C
authors: C
authors: Wei
authors: R
authors: R
authors: Li
authors: G
authors: G
authors: Yuan
authors: X
authors: X
authors: Liu
authors: B
authors: B
authors: Wang
authors: R
authors: R
authors: Guo
mesh_terms: D000328:Adult; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D011719:Pyrazines / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D011719:Pyrazines; D013607:Tablets; C027696:acipimox