NDLI: Prevalence of Desloratadine Slow-metabolizer Phenotype and Food-dependent Pharmacokinetics of Desloratadine in Healthy Chinese Volunteers.

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Prevalence of Desloratadine Slow-metabolizer Phenotype and Food-dependent Pharmacokinetics of Desloratadine in Healthy Chinese Volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Wang, Ting Zhang, Kun Li, Tingting He, Lin Xie, Huiru Jiang, Xuehua Wang, Ling
Description	Country affiliation: China Author Affiliation: Wang T ( Department of Clinical Pharmacy and Pharmacy Administration, Key Laboratory of Drug Ministry of Education, West China School of Pharmacy, Sichuan University, No.17, Block 3, Southern Renmin Road, Chengdu, 610041, China.); Zhang K ( Department of Clinical Pharmacy and Pharmacy Administration, Key Laboratory of Drug Ministry of Education, West China School of Pharmacy, Sichuan University, No.17, Block 3, Southern Renmin Road, Chengdu, 610041, China.); Li T ( Pharmacy Department, People's Hospital of Xishuangbanna Dai Autonomous Prefecture, Yunnan, China.); He L ( Department of Pharmacy, Sichuan Provincial People's Hospital, Sichuan, China.); Xie H ( Department of Clinical Pharmacy and Pharmacy Administration, Key Laboratory of Drug Ministry of Education, West China School of Pharmacy, Sichuan University, No.17, Block 3, Southern Renmin Road, Chengdu, 610041, China.); Jiang X ( Department of Clinical Pharmacy and Pharmacy Administration, Key Laboratory of Drug Ministry of Education, West China School of Pharmacy, Sichuan University, No.17, Block 3, Southern Renmin Road, Chengdu, 610041, China.); Wang L ( Department of Clinical Pharmacy and Pharmacy Administration, Key Laboratory of Drug Ministry of Education, West China School of Pharmacy, Sichuan University, No.17, Block 3, Southern Renmin Road, Chengdu, 610041, China. rebeccawang312@gmail.com.)
Abstract	BACKGROUND AND OBJECTIVES: Desloratadine, the major active metabolite of loratadine, is a non-sedating long-acting antihistamine that is widely used in the treatment of allergic rhinitis and chronic idiopathic urticaria. This study aimed to investigate the prevalence of desloratadine slow-metabolizer (DSM) phenotype and the effects of food on the pharmacokinetics of desloratadine and its active metabolite 3-OH-desloratadine in healthy Chinese volunteers. METHODS: A total of 46 healthy Chinese male volunteers were included in this investigation. All subjects received a single dose of a 5-mg desloratadine tablet under fasting or fed conditions and the plasma concentrations of desloratadine and 3-OH-desloratadine were measured by liquid chromatography-tandem mass spectrometry. The pharmacokinetic profiles were analyzed using a non-compartmental method in the Phoenix WinNonlin program. The individuals with a 3-OH-desloratadine-to-desloratadine exposure ratio lower than 10 % or a desloratadine half-life (t 1/2) of ≥50 h were supposed to be DSM. RESULTS: There was only one DSM among the 46 volunteers, with a prevalence of 2.2 %. Moreover, administration in a fed state resulted in 34.07 and 32.06 % decreases in maximum plasma concentration and area under the concentration-time curve from time zero to infinity for desloratadine and 47.26 and 48.46 % for 3-OH-desloratadine compared with those values under fasting conditions. CONCLUSIONS: Taken together, these results indicated that the incidence of the DSM phenotype in the Chinese population was low and that food intake could significantly decrease the absorption rate and extent of desloratadine.
File Format	HTM / HTML
ISSN	11732563
Issue Number	12
Volume Number	35
e-ISSN	11791918
Journal	Clinical Drug Investigation
Language	English
Publisher	Springer
Publisher Date	2015-12-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Asian Continental Ancestry Group Dietary Fats Metabolism Food-drug Interactions Physiology Histamine H1 Antagonists, Non-sedating Loratadine Analogs & Derivatives Phenotype Adolescent Adult Area Under Curve Cross-over Studies Diet, High-fat Methods Fasting Healthy Volunteers Humans Male Prevalence Young Adult Journal Article
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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