Bioavailability of acitretin capsules in healthy subjects
- VernacularTitle:阿维A胶囊人体生物等效性研究
- Author:
Hua MENG
- Publication Type:Journal Article
- Keywords:
Acitretin;
Bioavailability;
Bioequivalence;
HPLC
- From:
Journal of Chongqing Medical University
1986;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the relative bioavailability and pharmacokinetics of domestic acitretin capsules in 22 healthy male volunteers.Methods:A single dose of 50mg of domestic or imported acitretin was administered by randomized crossover way in 22 volunteers and the plasma concentrations of acitrctin were determined by HPLC.The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalency was evaluated.Results:The concentration-time curves of two preparations fitted one-compartment model.The peak plasma levels(C max )of domestic and imported acitretin were 490.51?136.50 and 470.91?118.59ng/ml respectively.The peak time(T max ) were 4.13?1.16 and 3.75?1.18h respectively.And AUC (0～24) were 2891.97?809.60 and 2883.01?905.60ng?h?ml -1 respectively.The relative bioavailability of domestic acitretin capsule was 100.23?11.03%.Conclusion:The result of two one-sided tests suggests that the domestic capsule is bioequivalent to the imported capsule.
