Pharmacokinetic and bioavailability studies using 5 mg mosapride tablets in healthy Korean volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 50, Issue 7, 2012, Pages 524-531

  Kim, Shin Hee ^a   Park, Yoo Sin ^a   Kim, Jung Mogg ^a   Park, Hae Jeong ^a   Lee, Min Ho ^a   Park, Hoon Ki ^a   Kim, Young Jae ^a   Cho, Sam Hyun ^a   Shaw, Leslie M ^b   Kang, Ju Seop ^a  

^a Hanyang University   (South Korea)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Bioequivalence study; LC MS MS; Mosapride; Pharmacokinetics

Indexed keywords

MOPRID; MOSAPRIDE; UNCLASSIFIED DRUG;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CONTROLLED STUDY; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; KOREA; LIMIT OF QUANTITATION; MALE; MAXIMUM PLASMA CONCENTRATION; OUTCOME ASSESSMENT; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; VALIDATION PROCESS;

ADULT; BENZAMIDES; BIOLOGICAL AVAILABILITY; CHROMATOGRAPHY, LIQUID; CROSS-OVER STUDIES; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; MALE; MORPHOLINES; TABLETS; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 84863692340     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201506     Document Type: Article

References (33)

1. Hiyama T, Yoshihara M, Tanaka S, Haruma K, Chayama K. Strategy for treatment of nonerosive reflux disease in Asia. World J Gastroenterol. 2008; 14: 3123-3128. doi:10.3748/wjg.14.3123 PubMed
2. McCallum RW, Cynshi O; Investigative Team. Clinical trial: effect of mitemcinal (a motilin agonist) on gastric emptying in patients with gastroparesis - a randomized, multicentre, placebo-controlled study. Aliment Pharmacol Ther. 2007; 26: 1121-1130 . doi:10.1111/j.1365-2036.2007.03461.x PubMed
3. Traut U, Brügger L, Kunz R, Pauli-Magnus C, Haug K, Bucher HC, Koller MT. Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults. Cochrane Database Syst Rev. 2008; CD004930. PubMed
4. Shende D, Mandal NG. Efficacy of ondansetron and metoclopramide for preventing postoperative emesis following strabismus surgery in children. Anaesthesia. 1997; 52: 496-500. doi:10.1111/j.1365-2044.1997.101-az0098.x PubMed (Pubitemid 27214161)
5. Scuderi PE, Weaver RG Jr, James RL, Mims G, Elliott WG, Weeks DB. A randomized, double-blind, placebo controlled comparison of droperidol, ondansetron, and metoclopramide for the prevention of vomiting following outpatient strabismus surgery in children. J Clin Anesth. 1997; 9: 551-558. doi:10.1016/S0952-8180(97)00143-8 PubMed (Pubitemid 27451256)
6. Smith PV, Walton DS. Prevention of vomiting after general anesthesia for pediatric ophthalmic surgery. AANA J. 2001; 69: 39-43. PubMed (Pubitemid 32183520)
7. Yoshida N. [Pharmacological effects of the gastroprokinetic agent mosapride citrate]. Nippon Yakurigaku Zasshi. 1999; 113: 299-307. doi:10.1254/fpj.113.299 PubMed
8. Curran MP, Robinson DM. Mosapride in gastrointestinal disorders. Drugs. 2008; 68: 981-991. doi:10.2165/00003495-200868070-00007 PubMed
9. Yoshida N, Ito T, Karasawa T, Itoh Z. AS-4370, a new gastrokinetic agent, enhances upper gastrointestinal motor activity in conscious dogs. J Pharmacol Exp Ther. 1991; 257: 781-787. PubMed
10. Yoshida N, Omoya H, Oka M, Furukawa K, Ito T, Karasawa T. AS-4370, a novel gastrokinetic agent free of dopamine D2 receptor antagonist properties. Arch Int Pharmacodyn Ther. 1989; 300: 51-67. PubMed (Pubitemid 20000046)
11. Hashizuma T. Identification of human metabolic enzyme P 450 relating the metabolism of mosapride citrate [in Japanese]. Bulletin of Dainippon Pharmaceutical Co.Ltd.1989
12. Katoh T, Saitoh H, Ohno N, Tateno M, Nakamura T, Dendo I, Kobayashi S, Nagasawa K. Drug interaction between mosapride and erythromycin without electrocardiographic changes. Jpn Heart J. 2003; 44: 225-234. doi:10.1536/jhj.44.225 PubMed (Pubitemid 41519021)
13. Sakashita M, Mizuki Y, Yamaguchi T, Miyazaki H, Sekine Y. Pharmacokinetics of the gastrokinetic agent mosapride citrate after intravenous and oral administrations in dogs and monkeys. Arzneimittelforschung. 1993; 43: 864-866. PubMed (Pubitemid 23254935)
14. Hsu MH, Savas U, Griffin KJ, Johnson EF. Human cytochrome p450 family 4 enzymes: function, genetic variation and regulation. Drug Metab Rev. 2007; 39: 515-538. doi:10.1080/03602530701468573 PubMed (Pubitemid 47355735)
15. Yamaori S, Yamazaki H, Iwano S, Kiyotani K, Matsumura K, Saito T, Parkinson A, Nakagawa K, Kamataki T. Ethnic differences between Japanese and Caucasians in the expression levels of mRNAs for CYP3A4, CYP3A5 and CYP3A7: lack of co-regulation of the expression of CYP3A in Japanese livers. Xenobiotica. 2005; 35: 69-83. doi:10.1080/00498250400021796 PubMed (Pubitemid 40459218)
16. Schellens JH, Soons PA, Breimer DD. Lack of bimodality in nifedipine plasma kinetics in a large population of healthy subjects. Biochem Pharmacol. 1988; 37: 2507-2510. doi:10.1016/0006-2952(88)90238-9 PubMed
17. Ahsan CH, Renwick AG, Macklin B, Challenor VF, Waller DG, George CF. Ethnic differences in the pharmacokinetics of oral nifedipine. Br J Clin Pharmacol. 1991; 31: 399-403. PubMed
18. Sowunmi A, Rashid TJ, Akinyinka OO, Renwick AG. Ethnic differences in nifedipine kinetics: comparisons between Nigerians, Caucasians and South Asians. Br J Clin Pharmacol. 1995; 40: 489-493. PubMed
19. Shimada T, Yamazaki H, Mimura M, Inui Y, Guengerich FP. Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians. J Pharmacol Exp Ther. 1994; 270: 414-423. PubMed (Pubitemid 24229655)
20. Ramakrishna NV, Vishwottam KN, Manoj S, Koteshwara M, Chidambara J, Varma DP. Validation and application of a high-performance liquid chromatography - tandem mass spectrometry assay for mosapride in human plasma. Biomed Chromatogr. 2005; 19: 539-548. doi:10.1002/bmc.477 PubMed (Pubitemid 41320499)
21. Ramakrishna NVS, Koteshwara M, Vishwottam KN, Puran S, Manoj S, Santosh M. Simple, sensitive and rapid LC-MS/MS method for the quantitation of cerivastatin in human plasma--application to pharmacokinetic studies. J Pharm Biomed Anal. 2004; 36: 505-515. doi:10.1016/j.jpba.2004.06.022 PubMed (Pubitemid 39441320)
22. FDA (Food and Drug Administration). Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drugs Products - General Considerations. US Dept of Health and Human Services, FDA, Center for Drug Evaluation and Research (CDER); 2003.
23. International Conference on Harmonization of Technical Requirements for the Resistration of Pharmaceuticals for Human Use. Validation of analytical procedures. Methodology. Geneva. 1996.
24. Hyder AA, Human D, Crawley F, IJsselmuiden C, Singer PA, Benatar SR. Revised declaration of Helsinki. Ethics is not just for ethicists. BMJ. 2001; 323: 283. doi:10.1136/bmj.323.7307.283 PubMed
25. Shumaker RC. PKCALC: a BASIC interactive computer program for statistical and pharmacokinetic analysis of data. Drug Metab Rev. 1986; 17: 331-348. doi:10.3109/03602538608998295 PubMed (Pubitemid 17044697)
26. KFDA (Korea Food and Drug Administration). Guideline for bioequivalence test. BA-Calc 1.0, KOREA, 2007.
27. Chow SC and Liu JP. Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker Inc, 1992
28. KFDA (Korea Food and Drug Administration). Guideline on food-effect bioavailability and fed bioequivalence studies, KOREA. 2005.
29. Sakashita M, Yamaguchi T, Miyazaki H, Sekine Y, Nomiyama T, Tanaka S, Miwa T, Harasawa S. Pharmacokinetics of the gastrokinetic agent mosapride citrate after single and multiple oral administrations in healthy subjects. Arzneimittelforschung. 1993; 43: 867-872. PubMed (Pubitemid 23254936)
30. Itoh H, Nagano T, Takeyama M. Effects of mosapride citrate on human plasma levels of motilin, gastrin, somatostatin, and secretin. Biol Pharm Bull. 2001; 24: 1072-1075. doi:10.1248/bpb.24.1072 PubMed (Pubitemid 32895500)
31. Evans WE, Johnson JA. Pharmacogenomics: the inherited basis for interindividual differences in drug response. Annu Rev Genomics Hum Genet. 2001; 2: 9-39. doi:10.1146/annurev.genom.2.1.9 PubMed (Pubitemid 35264999)
32. Ross AM, Gao R, Coyne KS, Chen J, Yao K, Yang Y, Qin X, Qiao S, Yao M; TUCC Investigators. A randomized trial confirming the efficacy of reduced dose recombinant tissue plasminogen activator in a Chinese myocardial infarction population and demonstrating superiority to usual dose urokinase: the TUCC trial. Am Heart J. 2001; 142: 244-247. doi:10.1067/mhj.2001.116963 PubMed (Pubitemid 32706281)
33. Hiroki I, Toshiaki N, Masahura T. Effects of mosapride citrate on human plasma levels of motilin, gastrin, somotostatin ans secretin. Bio pharm Bull. 2001; 24: 1072-1075.