Pharmacokinetics and safety of pitavastatin calcium tablets in Chinese healthy volunteers after a single oral dose administration
10.3969/j.issn.1001-6821.2010.03.009
- VernacularTitle:单剂量口服匹伐他汀钙片在中国健康志愿者的药代动力学和安全性
- Author:
Xiao XU
1
;
Jian-Zhong SHEN-TU
;
Jian LIU
;
Jun-Chun CHEN
;
Xing-Jiang HU
;
Ming-Zhu HUANG
;
Hui-Li ZHOU
;
Guo-Lan WU
Author Information
1. 温岭市第一人民医院
- Keywords:
HPLC-MS/MS;
pitavastatin;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(3):195-200
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the pharmacokinetics and safety of single dose of pitavastatin calcium tablets in Chinese healthy volunteers. Methods Twelve volunteers were divided into three groups by 3 × 3 de-sign. The drug concentrations of plasma sample from the twelve volun-teers after taking 1, 2 and 4 mg pitavastatin calcium tablets respectively were determined by LC-MS/MS. The pharmacokinetic parameters were calculated by Das 2. 0 software. Results The main pharmacokinetic pa-rameters of pitavastatin after single oral doses (1 mg, 2 mg and 4 mg) were as follows: t_(1/2β) were (11.39±7. 66), (10. 00±7.30), (11.30 ±7.95) h; t_(max) were (0. 83±0. 29), (0. 73±0. 20), (0. 85±0. 46) h; C_(max) were (30.48±11.66), (60.80±22.97), (120.98±35.51)ng ·mL~(-1) ; AUC_(0→72h) were (93. 19 ± 26. 61), (179. 46 ± 52. 86), (364. 37± 94.74) ng·mL~(-1)·h;AUC_(0→∞) were (96.70±27.42),(183.34±53. 62), (372. 86 ± 95.84) ng·mL~(-1)·h. The pharmacokinetic parame-ters such as C_(max), AUC_(0→72h), AUC_(0→∞) directly proportion to doses. There were no significant difference in K_(10), t_(max), t_(1/2β), MRT_(0-72h), MRT_(0→∞), CL/F, WF of three groups by analysis of variance. Conclusion The phannacokinetics of pitavastatin in the dosage of 1-4 mg in human body nearly fit linear dynamic feature. The main pharmacokinetic parameters are similar to those in the reported literature.
