Pharmacokinetics and relative bioavailability of gemfibrozil capsules in 12 healthy volunteers
- VernacularTitle:吉非罗齐在12名健康自愿者的药物动力学和相对生物利用度的研究
- Author:
Tao JIANG
;
Wei-Ren XU
;
- Publication Type:Journal Article
- Keywords:
gemfibrozil;
pharmacokinetics;
relative bioavailability;
HPLC;
human
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
1999;0(04):-
- CountryChina
- Language:Chinese
-
Abstract:
Aim The pharmacokinetic parameters and relative bioavailability of capsule A(Maiwei Pharmaceutical Co Ltd, Beijing, China) and capsule B (Xianjing Pharmaceu-tical, Hunan, China) were studied. Methods A single oral dose of 600 mg gemfibrozilof these two kinds of capsules was given to 12 chinese healthy male volunteers in anopen, randomized crossover study. Plasma levels were determined with HPLC-UVmethod. Results The plasma concentration-time curve was fitted to 1-compartmentopen model with a first order and lag time absorption and the major pharmacokineticparameters of capsules A and B were shown respectively as following: C max(32. 69?5. 67 )and (29. 41?2. 60) mg?L-1; Tmax (1. 01?0. 14) and (1. 13?0. 37) h, t1/2ka(0. 46 ? 0. 18) and (0. 62 ? 0. 20) h; C max (1. 11 ? 0. 32) and (1. 32 ? 0. 26) h; MRT(2. 14 ? 0.27) and (2. 37 ? 0.26) h; AUC (91.7 ? 13.2) and (82.2 ? 7. 38) mg?h? L-1. There were no significantly differences between the pharmacokinetic parame-ters of capsule A and B. The relative bioavailability of the capsule A was (110 ? 9) % ascompared to the capsule B. Conclusion The two kinds of capsules have the equivalentbiological effects.
