Comparative single- and multiple-dose pharmacokinetics of rosuvastatin following oral administration in Chinese volunteers. 2009

Yunxia Li, and Xuehua Jiang, and Ke Lan, and Qian Jiang
West China School of Pharmacy, Sichuan University, 610041, Sichuan, China.

The objective of this study was to determine and compare the plasma concentrations of rosuvastatin following single- and multiple-dose administration in Chinese volunteers. The study was of an open label, randomized, three-way cross-over design and was conducted in 12 subjects. Single dose administration of the rosuvastatinon was characterized by a rapid absorption (2.045 +/- 0.891 h, 2.273 +/- 1.009 h and 1.667 +/- 0.651 h) and a marked peak plasma concentration (9.938 +/- 4.438, 28.09 +/- 12.075 and 43.092 +/- 22.09 ng/ml) for the three different doses (5 mg, 10 mg and 20 mg) of rosuvastatin. The apparent elimination half-life amounted to 7.914 +/- 3.813 h, 8.445 +/- 4.994 h and 15.401 +/- 5.429 h following administration, respectively. Similar findings were obtained after multiple dosing. A rapid absorption (3 +/- 1.365 h, 3.042 +/- 1.054 h and 2.375 +/- 0.829 h) and a marked peak plasma concentration (9.288 +/- 5.314, 18.808 +/- 6.687 and 49.808 +/- 23.516 ng/ml) for the three different doses (5 mg, 10 mg and 20 mg) of rosuvastatin were observed. The apparent elimination half-life amounted to 13.181 +/- 5.492 h, 8.035 +/- 3.331 h and 15.509 +/- 6.43 h following administration, respectively. Small differences in gender are not considered clinically relevant, and dose adjustments based on gender are not anticipated. But the state of fed or fasting will affect the pharmacokinetic of rosuvastatin.

UI MeSH Term Description Entries
D008297 Male Males
D011743 Pyrimidines A family of 6-membered heterocyclic compounds occurring in nature in a wide variety of forms. They include several nucleic acid constituents (CYTOSINE; THYMINE; and URACIL) and form the basic structure of the barbiturates.
D002681 China A country spanning from central Asia to the Pacific Ocean. Inner Mongolia,Manchuria,People's Republic of China,Sinkiang,Mainland China
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D004334 Drug Administration Schedule Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience. Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D005260 Female Females
D005464 Fluorobenzenes Derivatives of BENZENE that contain FLUORINE. Fluorobenzene
D006207 Half-Life The time it takes for a substance (drug, radioactive nuclide, or other) to lose half of its pharmacologic, physiologic, or radiologic activity. Halflife,Half Life,Half-Lifes,Halflifes
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000068718 Rosuvastatin Calcium A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES. Crestor,Rosuvastatin,ZD 4522,ZD4522,Calcium, Rosuvastatin

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