Phase I Study of CD-13, a Diagnostic Agent for H. Pylori Infection Used in the 13C-Urea Breath Test.
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Accession number;99A0260306
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| Title;Phase I Study of CD-13, a Diagnostic Agent for H. Pylori Infection Used in the 13C-Urea Breath Test. |
| Author;
MIWA TSUYOSHI
(Tokai Univ., Hosp.)
NAKAMURA TSUYOSHI
(Tanashidaiichibyoin)
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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.1;PAGE.53-65(1999)
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| Figure&Table&Reference;FIG.8, TBL.6, REF.13 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Safety and pharmacokinetics of single oral administration of CD-13, a diagnostic agent for the 13C-Urea Breath Test(13C-UBT), at doses of 50,100 and 200mg were examined on 36 healthy male volunteers(including Helicobacter pylori positives and negatives). There were no abnormal findings at any dose levels in physiological function, electrocardiography, symptoms, clinical signs or laboratory values. The unchanged drug concentration in plasma peaked(Cmax) at 35-83 minutes(Tmax) after administration. Elimination half life(t1/2) of the unchanged drug was 12-16 hours. Cmax and area under the unchanged drug plasma concentration-time curve until 24 hours after administration(AUC0-24) tended to increase dose-dependently in either H. pylori positives or negatives. Urinary excretion of the unchanged drug until 24 hours after administration was 56-86% of the dose administered. Concentration change of 13C-carbon dioxide over time in exhalation was definitely different between H. Pylori positives and negatives, suggesting usefulness of CD-13 as a diagnostic agent used for the 13C-UBT. Based on the results of this study, it was concluded that more than 100mg of CD-13 should be administrated to determine H. pylori infection. (author abst.) |
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