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Study on the pharmacokinetic profile of telbivudine / 中华肝脏病杂志
Chinese Journal of Hepatology ; (12): 811-813, 2006.
Article in Chinese | WPRIM | ID: wpr-260586
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the pharmacokinetic profile of telbivudine in healthy Chinese subjects after oral administration of single and multiple doses.</p><p><b>METHODS</b>Forty-two healthy adult male and female subjects 18-40 years of age were randomized into four telbivudine dosing groups of 200 mg, 400 mg, 600 mg and 800 mg. Subjects in the 600 mg group received both a single dose and once daily multiple doses for 8 consecutive days. Telbivudine concentrations in plasma and urine samples collected at different time points before and after the drug administration were measured using HPLC-MS/MS. Pharmacokinetic parameters were calculated by using the non-compartmental approach.</p><p><b>RESULTS</b>After a single dose of 200 mg, 400 mg, 600 mg and 800 mg, tmax (median) were 2.50, 2.00, 2.00 and 2.50 hours respectively; t1/2 were (43.3 +/- 15.2) h, (49.1 +/- 14.4) h, (39.4 +/- 12.1) h and (46.7 +/- 20.8) h respectively; Cmax were (1,753.2 +/- 389.0) ng/ml, (2,586.7 +/- 871.4) ng/ml, (3,703.6 +/- 1,219.0) ng/ml and (3454.6 +/- 953.9) ng/ml respectively; AUC(0-infinity) were (12,843.2 +/- 2,925.6) ng.h(-1).ml(-1), (22,948.9 +/- 5,721.0) ng.h(-1)/ml(-1), (26,440.5 +/- 8,938.1) ng.h(-1).ml(-1) and (28, 820.9 +/- 7 912.9) ng.h(-1).ml(-1) respectively, and CL(R) (600 mg) was (6,545.6 +/- 1 504.4) ml/h. The AUCss from multiple doses was (1,088.5 +/- 299.8) ng/ml; Cmax and AUC accumulation ratio were 1.02 +/- 0.21 and 1.23 +/- 0.26 respectively, which implicated moderated accumulation.</p><p><b>CONCLUSION</b>Pharmacokinetic parameters of telbivudine in Chinese healthy subjects were determined.</p>
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Full text: Available Index: WPRIM (Western Pacific) Main subject: Pyrimidinones / Thymidine / Pharmacokinetics / Dose-Response Relationship, Drug / Nucleosides Type of study: Controlled clinical trial Limits: Adolescent / Adult / Female / Humans / Male Language: Chinese Journal: Chinese Journal of Hepatology Year: 2006 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Pyrimidinones / Thymidine / Pharmacokinetics / Dose-Response Relationship, Drug / Nucleosides Type of study: Controlled clinical trial Limits: Adolescent / Adult / Female / Humans / Male Language: Chinese Journal: Chinese Journal of Hepatology Year: 2006 Type: Article