Pharmacokinetics of multiple doses ampiroxicam in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2014.10.014
- VernacularTitle:安吡昔康在健康受试者多次给药的药代动力学研究
- Author:
Cai-Yun ZHAO
1
;
Yuan LV
;
Min-Ji WEI
;
Zi-Sheng KANG
;
Yan LIU
;
Man ZHANG
Author Information
1. 北京大学 第一医院 临床药理研究所
- Keywords:
ampiroxicam;
piroxicam;
pharmacokinetic;
HPLC;
multiple -dose
- From:
The Chinese Journal of Clinical Pharmacology
2014;(10):915-918
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the pharmacokinetics of multiple doses of ampiroxicam tablets in Chinese healthy subjects .Methods A randomized, open study was conducted.Twelve subjects were orally administrated with 27 mg ampiroxicam tablets, once a day for 11 days. The blood samples were collected on the 8th , 9th , and 10th day before ad-ministration.On the 11 th day, the blood and urine samples were collected at different time points after administration , and the concentrations of am-piroxicam in serum and urine were determinated by HPLC method . Results One subject exited on the 7th day.The main pharmacokinetics parameters of 11 subjects after oral doses for 11 days were as follows:Cmax were(8.14 ±2.81) mg? L-1; t1 /2β was (50.10 ±18.10 ) h; tmax was (5.60 ±4.10) h; AUC0 -∞ was (837.05 ±441.47 ) mg? h? L respectively.Urinary recovery rate was (0.55 ±0.51 )% from zero to 192 hours, respectively.Conclusion After multiple dosing, there was a very high trough concentration before dosing because of a very long half -life of ampiroxicam.Blood concentration and pharmacokinetic parameters are individually different, and little drug is excreted by kidney.