NDLI: Effect of food on the pharmacokinetic properties of the oral sarpogrelate hydrochloride controlled-release tablet in healthy male Korean subjects.

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Effect of food on the pharmacokinetic properties of the oral sarpogrelate hydrochloride controlled-release tablet in healthy male Korean subjects.

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Effect of food on the pharmacokinetic properties of the oral sarpogrelate hydrochloride controlled-release tablet in healthy male Korean subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Jung, Jin Ah Kim, Jung-Ryul Kim, Tae-Eun Lee, Soo-Youn Huh, Wooseong Lee, Jae Won Jun, Hun Ko, Jae-Wook
Description	Author Affiliation: Jung JA ( Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.)
Abstract	BACKGROUND: A new controlled-release formulation of sarpogrelate, a 5-hydroxytryptamine receptor subtype 2 antagonist that blocks serotonin-induced platelet aggregation, has been developed for once-daily administration. OBJECTIVE: This study evaluated the effect of food on the pharmacokinetic properties of controlled-release sarpogrelate (sarpogrelate CR) in healthy volunteers. METHODS: A randomized, open-label, two-period, two-treatment crossover study was performed in healthy male Korean subjects. Following an overnight fast, a single dose of sarpogrelate CR 300 mg was administered either in the fasted condition or immediately after a high-fat breakfast. Pharmacokinetic parameters were calculated using a noncompartmental analysis. Tolerability was determined using clinical laboratory testing and physical examination, including vital sign measurements, electrocardiography, and interviews with the volunteers regarding adverse events (AEs). RESULTS: A total of 24 healthy subjects were enrolled, 23 of whom completed the study (mean [range] age, 26 years [21-45]; weight, 68.1 kg [56.0-79.9]; body mass index, 22.1 kg/m(2) [18.8-25.0]). Sarpogrelate C(max) and AUC(last) were decreased In the fed condition compared with those in the fasted condition, with geometric mean ratios (90% CI) of 0.4868 (0.4041-0.5864) and 0.7394 (0.6809-0.8028), respectively. T(max) was delayed from 0.75 to 4.0 hours after a high-fat meal, but the fed condition exhibited a similar elimination profile to that of the fasted condition. The most commonly reported AE was headache (n = 2), and other AEs were reported in 1 subject each. All of the AEs were considered mild in intensity, and the participants recovered without treatment. CONCLUSIONS: Compared with the administration of sarpogrelate CR 300 mg in the fasted condition, administration with food was associated with a decreased rate and extent of absorption, as assessed by C(max) and AUC(last), respectively. The drug was well-tolerated by the healthy subjects in this study.
File Format	HTM / HTML
ISSN	01492918
Issue Number	7
Volume Number	35
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2013-07-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Food-drug Interactions Food Succinates Pharmacokinetics Administration, Oral Adult Asian Continental Ancestry Group Cross-over Studies Delayed-action Preparations Drug Administration Schedule Drug Tolerance Healthy Volunteers Humans Male Middle Aged Administration & Dosage Tablets, Enteric-coated Clinical Trial 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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