Pharmacokinetics of a new once-daily controlled-release sarpogrelate hydrochloride compared with immediate-release formulation and the effect of food

Journal of Clinical Pharmacy and Therapeutics

Volumn 39, Issue 2, 2014, Pages 192-195

  Kim, T E ^a   Kim, J R ^b,d   Jung, J A ^b,c   Kim, M J ^b   Lee, S Y ^b   Ko, J W ^b,c   Jung, W T ^e   Choi, Y W ^c,e   Lee, H J ^f   Kim, S H ^d,f   Huh, W ^b,c  

^a Konkuk University Hospital   (South Korea)

^b Samsung Medical Center   (South Korea)

^c Sungkyunkwan University School of Medicine   (South Korea)

^d Sungkyunkwan University   (South Korea)

^e Global R and D Korea United Pharm Inc   (South Korea)

^f Caleb Multilab Inc   (South Korea)

Author keywords

controlled release; food effect; pharmacokinetics; sarpogrelate

Indexed keywords

BILIRUBIN; HEMOGLOBIN; SARPOGRELATE;

ABDOMINAL DISTENSION; ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AREA UNDER THE CURVE; ARTICLE; BILIRUBIN BLOOD LEVEL; BLOOD SAMPLING; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SCREENING; FOOD; FOOD DRUG INTERACTION; HEADACHE; HUMAN; IMMEDIATE RELEASE FORMULATION; LIQUID CHROMATOGRAPHY; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; NAUSEA; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; TANDEM MASS SPECTROMETRY; YOUNG ADULT;

5-HYDROXYTRYPTAMINE RECEPTOR SUBTYPE 2A (5HT2A); CONTROLLED RELEASE; FOOD EFFECT; PHARMACOKINETICS; SARPOGRELATE;

ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CHROMATOGRAPHY, LIQUID; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; FOOD-DRUG INTERACTIONS; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; PLATELET AGGREGATION INHIBITORS; SUCCINATES; TANDEM MASS SPECTROMETRY; YOUNG ADULT;

EID: 84895519907     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/jcpt.12117     Document Type: Article

References (13)

1. Jacobs BL, Azmitia EC,. Structure and function of the brain serotonin system. Physiol Rev, 1992; 72: 165-229.
2. Herve P, Launay JM, Scrobohaci ML, et al,. Increased plasma serotonin in primary pulmonary hypertension. Am J Med, 1995; 99: 249-254.
3. Cote F, Fligny C, Fromes Y, Mallet J, Vodjdani G,. Recent advances in understanding serotonin regulation of cardiovascular function. Trends Mol Med, 2004; 10: 232-238.
4. Nagatomo T, Rashid M, Abul Muntasir H, Komiyama T. Functions of 5-HT2A receptor and its antagonists in the cardiovascular system. Pharmacol Ther, 2004; 104: 59-81.
5. Tanaka T, Fujita M, Nakae I, et al,. Improvement of exercise capacity by sarpogrelate as a result of augmented collateral circulation in patients with effort angina. J Am Coll Cardiol, 1998; 32: 1982-1986.
6. Fujita M, Mizuno K, Ho M, et al,. Sarpogrelate treatment reduces restenosis after coronary stenting. Am Heart J, 2003; 145: E16.
7. Usui A, Takagi Y, Ohara Y, Kawaguchi O, Watanabe T, Ueda Y,. Sarpogrelate reduces mechanical hemolysis in patients with heart valve prostheses. Jpn J Thorac Cardiovasc Surg, 2000; 48: 769-774.
8. Igarashi M, Okuda T, Oh-i T, Koga M,. Changes in plasma serotonin concentration and acceleration plethysmograms in patients with Raynaud's phenomenon after long-term treatment with a 5-HT2 receptor antagonist. J Dermatol, 2000; 27: 643-650.
9. Rydzewski A, Urano T, Hachiya T, Kaneko H, Baba S, Takada Y, Takada A,. The effect of a 5HT2 receptor antagonist sarpogrelate (MCI-9042) treatment on platelet function in Buerger's disease. Thromb Res, 1996; 84: 445-452.
10. Shinohara Y, Nishimaru K, Sawada T, et al,. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): a randomized, double-blind, aspirin-controlled trial. Stroke, 2008; 39: 1827-1833.
11. Guideline for Good Clinical Practice [database on the Internet]. [cited June 02, 2013]. Available from: http://www.ich.org/fileadmin/Public-Web-Site/ ICH-Products/Guidelines/Efficacy/E6-R1/Step4/E6-R1-Guideline.pdf (accessed 25 November 2013).
12. Malcolm Rowland TNT,. Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications, 4th edn., Baltimore, MD, and, Philadelphia, PA,: Lippincott Williams & Wilkins, A Wolters Kluwer Business: 2011.
13. Uchiyama S, Ozaki Y, Satoh K, Kondo K, Nishimaru K,. Effect of sarpogrelate, a 5-HT(2A) antagonist, on platelet aggregation in patients with ischemic stroke: clinical-pharmacological dose-response study. Cerebrovasc Dis, 2007; 24: 264-270.