[Pharmacokinetics and relative bioavailability of KC-404 sustained release tablets in healthy volunteers].
OBJECTIVE
To study the pharmacokinetics and relative bioavailability of KC-404 sustained release tablets and capsules in healthy volunteers.


METHODS
The concentration of KC-404 in serum was determined by HPLC method after a single oral dose (20 mg) of tablet or capsule was administered to 19 healthy male volunteers respectively in an open randomized cross-over test.


RESULTS
After being processed by 3P87 pharmacokinetics program, the experiment data showed that the pharmacokinetic parameters of the tablets and the capsules were AUC0-->infinity: 740.12 ng.h/ml and 724.04 ng.h/ml; tmax: 5.37 h and 5.11 h; Cmax: 46.98 ng/ml and 46.29 ng/ml; T1/2: 7.4 h and 7.0 h; MRT0-->infinity: 14.78 h and 14.39 h respectively. There were no significant differences in AUC, tmax, Cmax, T1/2 and MRT0-->infinity between these two preparations (P > 0.05). The relative bioavailability of KC-404 sustained release tablets was 102.6%.


CONCLUSIONS
These two preparations are bioequivalent.
Li
Tongling
T
Department of Clinic Pharmacy, West China School of Pharmacy, Sichuan University, Chengdu 610041, China.
Pang
Yinuo
Y
Wang
Zhixiao
Z
Jia
Yurong
Y
Cheng
Qiang
Q
Sun
Jian
J
D000328:Adult; D001682:Biological Availability; D001993:Bronchodilator Agents / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D006801:Humans; D008297:Male; D011725:Pyridines / Q000493:pharmacokinetics*; D013607:Tablets; D014665:Vasodilator Agents / Q000493:pharmacokinetics*; D007212:Indolizines; D011720:Pyrazoles
D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; D011725:Pyridines; D013607:Tablets; D014665:Vasodilator Agents; C038366:ibudilast; D007212:Indolizines; D011720:Pyrazoles