Clinicoparmacological Study on Drug Interaction of Mosapride in Healthy Volunteers. Effects on Electrocardiogram and Pharmacokinetics by Concomitant Administration of Mosapride and Erythromycin.
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Accession number;99A0526254
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| Title;Clinicoparmacological Study on Drug Interaction of Mosapride in Healthy Volunteers. Effects on Electrocardiogram and Pharmacokinetics by Concomitant Administration of Mosapride and Erythromycin. |
| Author;
KATO TAKAO
(Nippon Med. Sch.)
SAITO HIROKAZU
(Nippon Med. Sch.)
ONO NORIHIKO
(Nippon Med. Sch.)
TATENO MASAO
(Niiza-Shiki Chuo Sogo Byoin)
NAKAMURA TSUYOSHI
(Niiza-Shiki Chuo Sogo Byoin)
DENDO ISAO
(Niiza-Shiki Chuo Sogo Byoin)
KOBAYASHI SHIN'ICHI
(St. Marianna Univ.)
NAGASAWA KOICHI
(Nippon Med. Sch., Tama Nagayama Hosp.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.15;NO.5;PAGE.753-763(1999)
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| Figure&Table&Reference;FIG.4, TBL.5, REF.29 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In 10 healthy adult male volunteers, 5mg of mosapride(GASMOTIN) was repeatedly administered 3 times a day for 7 days and, thereafter, 300mg of erythromycin was concomitantly given 4 times a day for 7 days, and effects on ECG and pharmacokinetics were investigated. As the results, 1) There found slightly soft stool in 3, mild diarrhea in 1 and slightly abdominal pain in 1 out of 10 cases for mosapride alone and/or concomitant administration with erythromycin. No abnormal changes were noted in blood pressure, heart rate, body temperature and clinical laboratory findings during the study periods. 2) By the concomitant use of erythromycin, the Cmax of mosapride increased 1.6 times and t1/2 was prolonged from 1.6hrs to 2.4hrs, indicating the inhibition of mosapride metabolism. 3) However, there were no significant differences in the RR interval, QT interval and QTc of ECG between the final day of the mosapride administration alone and the final day of concomitant use with erythromycin. 4) There was no correlation between ECG parameters and plasma mosapride concentrations, and no case exceeded the upper limit(0.44) of the normal range of QTc. It is concluded that mosapride and concomitant administrations with erythromycin did not affect the ECG findings at all, indicating less possibility of clinical adverse events in cardiovascular system. (author abst.) |
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