NDLI: Pharmacokinetics of single and repeated oral doses prucalopride in healthy Chinese volunteers.

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Pharmacokinetics of single and repeated oral doses prucalopride in healthy Chinese volunteers.

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Pharmacokinetics of single and repeated oral doses prucalopride in healthy Chinese volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Chen, Xia Jiang, Ji Liu, Tao Liu, Hongzhong Zhong, Wen Hu, Pei
Spatial Coverage	China
Description	Country affiliation: China Author Affiliation: Chen X ( Phase I Unit, Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.)
Abstract	AIM: This study investigated the pharmacokinetics of prucalopride in Chinese healthy volunteers. METHODS: This single-center, open-label study was conducted in 14 healthy males and 14 healthy females, aged 18 - 45 years. Fasted subjects received a single dose of 2 mg prucalopride, and after a 7-day wash-out period, they received the same dose once-daily for 7 days at fasted condition. Serial blood samples were taken at predefined time-points to measure plasma concentrations of prucalopride during the single-dose and multi-dose period. Daily evaluations were made on defecation frequency and stool consistency. Safety assessments were performed throughout the study. RESULTS: After oral administration, prucalopride reached the peak plasma level (Cmax) of 4.92 ± 0.78 ng/ml with a median time to Cmax (tmax) of 2 hours and resulted in an area under concentration-time curve (AUC0-∞) of 89.3 ± 15.82 h×ng/ml. Steady state was attained 3 days after repeated dosing, when Cmax was 8.09 ± 1.21 ng/ml and AUC0-24h was 103.6 ± 14.35 h×ng/ml. Pharmacokinetic profiles were similar between genders except males had a slightly lower exposure level. Marked increase of defecation frequencies and predominance of 'watery' or 'loose' stools were seen after a single dose. The responses during multi-dose period were less remarkable and returned to baseline in 3 days. CONCLUSION: The pharmacokinetics of prucalopride 2 mg oral dose in Chinese healthy volunteers are similar to those observed in Caucasians. Compared to females, males exhibited a slightly lower exposure of prucalopride but similar changes of bowel habits were observed in both genders suggesting the inter-gender pharmacokinetic differences are not clinically relevant.
File Format	HTM / HTML
ISSN	09461965
Issue Number	11
Volume Number	50
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2012-11-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology Asian Continental Ancestry Group Benzofurans Administration & Dosage Pharmacokinetics Defecation Drug Effects Gastrointestinal Agents Serotonin 5-ht4 Receptor Agonists Administration, Oral Adolescent Adult Area Under Curve Adverse Effects Blood China Drug Administration Schedule Female Humans Male Metabolic Clearance Rate Middle Aged Sex Factors Tablets Young Adult Clinical Trial Comparative Study Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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