NDLI: Pharmacokinetics and safety of bromotetrandrine (BrTet, W198) after single-dose intravenous administration in healthy Chinese volunteers.

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Pharmacokinetics and safety of bromotetrandrine (BrTet, W198) after single-dose intravenous administration in healthy Chinese volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Zheng, L. Qing, Y-P Xu, N. Yu, Q. Wang, Y. Wang, F-P Li, Z-Y
Spatial Coverage	China
Description	Country affiliation: China Author Affiliation: Zheng L ( Institute of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu, China. lzheng2005618@yahoo.com.cn)
Abstract	OBJECTIVE: To investigate the safety and pharmacokinetics of bromotetrandrine (BrTet, W198), a novel inhibitor of P-glycoprotein (P-gp), after single-dose i.v. infusion in healthy Chinese volunteers. METHODS: We conducted a randomized, dose-escalating, phase I clinical study for that purpose. Thirty healthy subjects received BrTet at the doses of 10, 20 or 30 mg/m(2) by i.v. infusion. Plasma and urine concentrations of bromotetrandrine were determined by using a liquid chromatography-tandem mass spectrometric (LC/MS/MS) method. AUC was calculated by the trapezoidal rule extrapolation method. C(max), T(max), t(1/2alpha), t(1/2beta), Cl and V(d) were compiled from the plasma concentration-time data. RESULTS: Bromotetrandrine was generally well tolerated at all doses. No serious or severe adverse events were found in the study. The pharmacokinetic parameters of BrTet after single i.v. infusion doses of BrTet 10, 20 and 30 mg/m(2) were as follows: T(max) were 1.5 h in three groups, C(max) were 24.79, 39.59 and 64.31 microg/L, t(1/2alpha) were 0.37, 0.29 and 0.30 h, t(1/2beta) were 62.88, 56.45 and 52.20 h. AUC(0-194h) were 345.83, 688.15 and 1096.28 microg h/L, Cl were 23.68, 25.69 and 25.66 L h/m(2), V(d) were 157.73,156.96 and 140.73 L/m(2). In urine, the total eliminate rate of originate compound was 0.61 +/- 0.19%. CONCLUSIONS: This study suggested that bromotetrandrine was well tolerated in healthy volunteers within the dose range evaluated. The pharmacokinetics parameters of bromotetrandrine indicated that the compound was rapidly distributed and accumulated in the tissues, and slowly cleared from plasma, which supported the use of BrTet for a once or twice dosing per chemotherapy cycle.
File Format	HTM / HTML
ISSN	02694727
Issue Number	1
Volume Number	35
e-ISSN	13652710
Journal	Journal of Clinical Pharmacy and Therapeutics
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2010-02-01
Publisher Place	Great Britain (UK)
Access Restriction	Subscribed
Subject Keyword	Discipline Therapeutics Discipline Pharmacology Antineoplastic Agents, Phytogenic Adverse Effects Pharmacokinetics Benzylisoquinolines P-glycoprotein Antagonists & Inhibitors Adult Administration & Dosage China Chromatography, High Pressure Liquid Female Half-life Humans Infusions, Intravenous Male Metabolic Clearance Rate Sex Characteristics Spectrometry, Mass, Electrospray Ionization Tandem Mass Spectrometry Young Adult Clinical Trial, Phase I Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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