NDLI: Pharmacokinetics of Orally Administered Single- and Multiple-Dose Olopatadine in Healthy Chinese Subjects

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Chu, Nan-Nan Chen, Wei-Li Xu, Hong-Rong Li, Xue-Ning
Description	Country affiliation: China Author Affiliation: Chu NN ( Department of Clinical Pharmacology, ZhongShan Hospital, Fudan University, Shanghai, China.)
Abstract	BACKGROUND AND OBJECTIVES: Olopatadine is a new selective histamine H(1) receptor antagonist with anti-inflammatory and anti-allergic effects. Its pharmacokinetics and safety have not previously been evaluated in Chinese subjects. The aims of this study were to assess the pharmacokinetics and safety of olopatadine after single- and multiple-dose oral administration in healthy Chinese subjects and to identify any differences in pharmacokinetics between males and females. METHODS: The pharmacokinetic parameters for olopatadine in 12 healthy Chinese subjects (six males and six females) were assessed by determining olopatadine concentrations with a validated liquid chromatography-tandem mass spectrometry method. Safety and tolerability were evaluated by monitoring adverse events, laboratory assay results, vital signs, physical examination findings and 12-lead ECG results. RESULTS: The pharmacokinetic parameters (mean +/- SD) for olopatadine following a single dose were: maximum plasma concentration (C(max)) 69.98 +/-20.87 ng/mL, time to reach C(max) (t(max)) 1.02 +/- 0.34 h, elimination half-life (t1/2) 5.87 +/- 4.24 h, area under the plasma-concentration curve (AUC) from time zero to the time of last quantifiable concentration (AUC(last)) 266.00 +/- 143.95 ng.h/mL, AUC from time zero extrapolated to infinity (AUC(infinity)) 283.46 +/- 152.96 ng.h/mL, apparent oral clearance (CL/F) 23.45 +/- 12.59 L/h and apparent volume of distribution after oral administration (V(d)/F) 133.83 +/- 43.07 L. The pharmacokinetic parameters of olopatadine after multiple doses were similar to those after a single dose. In both studies, significantly higher AUC(last), AUC(infinity) and C(max), longer t1/2 (single-dose only) and lower CL/F were observed in female subjects compared with male subjects after both single and multiple dosing. No serious adverse events occurred. CONCLUSION: Olopatadine was shown to be safe and well tolerated in healthy Chinese subjects. There were no changes in absorption and elimination of olopatadine following multiple doses and no accumulation was found. Possible sex-related differences in absorption and elimination of olopatadine were observed.
File Format	HTM / HTML
ISSN	11732563
Issue Number	7
Volume Number	29
e-ISSN	11791918
Journal	Clinical Drug Investigation
Language	English
Publisher	Springer
Publisher Date	2009-01-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Anti-inflammatory Agents, Non-steroidal Pharmacokinetics Dibenzoxepins Administration, Oral Pharmacology Area Under Curve Asian Continental Ancestry Group Chromatography, Liquid Dose-response Relationship, Drug Drug Administration Schedule Female Half-life Humans Male Olopatadine Hydrochloride Sex Factors Tandem Mass Spectrometry Young Adult Comparative Study Journal Article Research Support, Non-u.s. Gov't
Alternative Title	Pharmacokinetics of orally administered single- and multiple-dose olopatadine in healthy Chinese subjects: an open-label study
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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