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Journal of Bioequivalence & Bioavailability
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Research Article

An Assessment of the Pharmacokinetics and Tolerability of Single-Ascending Doses of Desvenlafaxine Administered to Healthy Chinese Subjects

Lingling Guan1§, Huafang Li2§*, Zhangjing Chen3, Glen Frick1 and Alice Nichols1

1Pfizer, Formerly Wyeth Research, Collegeville, Pennsylvania, USA

2Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China

3Pfizer, Formerly Wyeth Research, Shanghai, China

§Both authors contributed equally

*Corresponding Author:
Li Huafang, MD
PhD, Shanghai Mental Health Center
Shanghai Jiao Tong University School of Medicine 600
Wan Ping Nan Lu, Shanghai 200030, China
Tel: 86-21-34773128
Fax: 86-21-54240982
CP: 18017311256
E-mail: [email protected]

Received Date: October 05, 2015; Accepted Date: February 05, 2016; Published Date: February 12, 2016

Citation: Guan L, Li H, Chen Z, Frick G, Nichols A (2016) An Assessment of the Pharmacokinetics and Tolerability of Single-Ascending Doses of Desvenlafaxine Administered to Healthy Chinese Subjects. J Bioequiv Availab 8: 099-105. doi: 10.4172/jbb.1000276

Copyright: © 2016 Guan L, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Desvenlafaxine (administered as desvenlafaxine succinate) exhibited linear pharmacokinetics after singledose administration in a US population. The current study assessed the pharmacokinetics and tolerability of singleascending doses of desvenlafaxine in Chinese subjects. Healthy adult subjects of Chinese descent living in China were randomly assigned to receive either a single dose of desvenlafaxine 50, 100, 200 mg, or placebo in this sponsor-unblinded, inpatient, ascending-dose study. Desvenlafaxine concentrations in urine and plasma were measured using a validated liquid chromatography/tandem mass spectrometry method. Peak plasma concentration (Cmax) and time to Cmax (tmax) were determined directly from observed data, and area under the plasma concentrationversus- time curve (AUC) was computed. Dose proportionality for Cmax and AUC was examined using a power model. Tolerability was assessed through adverse event (AE) reporting. Thirty-six subjects were enrolled. The Cmax of desvenlafaxine increased 138% between the 50 mg (109 ng/mL) and 100 mg (259 ng/mL) doses. The Cmax for subjects receiving desvenlafaxine 200 mg was 654 ng/mL, a 153% increase compared with the 100 mg dose. The AUC of desvenlafaxine increased 127% from the 50 mg dose (2,520 ng•hr/mL) to the 100 mg dose (5,720 ng•hr/ mL), and 126% between the 100 mg and 200 mg (12,900 ng•hr/mL) doses. The power model analysis indicated dose proportionality for AUC, but not for Cmax. No serious AEs were reported. Desvenlafaxine was generally well tolerated in healthy Chinese subjects, and its exposure (AUC) was dose-proportional. Results from this study and studies in US, European, and Japanese populations indicate that the pharmacokinetics of desvenlafaxine were comparable between these ethnic groups.

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