Clinical Pharmacokinetic Study of A Single Oral Administration of Limaprost alfadex (Prorenal)
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Accession number;05A0310803
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| Title;Clinical Pharmacokinetic Study of A Single Oral Administration of Limaprost alfadex (Prorenal) |
| Author;
MIKAMI HIROSHI
(Osaka Pharmacol. Res. Clin.)
YABUNO TAKASHI
(Dainippon Pharm. Co., Ltd.)
TAKEMOTO YUICHI
(Dainippon Pharm. Co., Ltd.)
HISHITA NORIKO
(Osaka Pharmacol. Res. Clin.)
ITO TADAO
(Osaka Pharmacol. Res. Clin.)
AZUMA JUN'ICHI
(Osaka Univ., Graduate School of Pharmaceutical Sciences, JPN)
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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.21;NO.3;PAGE.361-366(2005)
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| Figure&Table&Reference;FIG.3, TBL.3, REF.10 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;1) Pharmacokinetics: Limaprost alfadex tablets (5.MU.g strength) were orally administered to 12 healthy Japanese male adults at a single dose of one tablet (5.MU.g) and two tablets (10.MU.g) so as to study the pharmacokinetic profile of this drug. The plasma concentration of the unchanged drug after the single dose of 5.MU.g or 10.MU.g reached Cmax from 0.5 to 2 hours after the administration and the plasma concentration decreased with a single elimination phase and a t1/2 of about 0.9 hours. The following pharmacokinetic parameters were calculated for both dose levels (i.e., 5.MU.g and 10.MU.g): CL/F, t1/2, Cmax, AUC0-4, and AUC0-.INF.. The ratio of the calculated pharmacokinetic parameter values (the calculated values of Cmax, AUC0-4, and AUC0-.INF. for the 5.MU.g g dose were doubled to allow comparison with those for the 10.MU.g dose) of the 5,.MU.g dose against those of the 10.MU.g dose fell within the range of 0.90 to 1.11. 2) Safety: Two out of 24 cases (the 12 volunteers were administered the test drug twice, i.e., at both 5.MU.g and 10.MU.g) developed 3 adverse events. The details of these adverse events are as follows. One case with the 5.MU.g dose developed two events of leukocytosis and pharyngitis. One case with the 10.MU.g dose developed elevated blood triglyceride. All of these adverse events were mild and returned to normal without any treatment, and the causality of all these cases with the study drug was determined to be "Denied". There were no safety concerns related to blood pressure, pulse rate, breathing rate, body temperature, or 12-lead electrocardiogram at rest. (author abst.) |
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