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Accession number;99A0451285
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| Title;Study of Safety and Pharmacokinetics of CLDM-T in Normal Volunteers. |
| Author;
HARADA SHOTARO
(Nippon Telegr. and Teleph. Corp. Kanto Teishin 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.4;PAGE.567-582(1999)
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| Figure&Table&Reference;FIG.7, TBL.9, REF.4 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Safety and pharmacokinetics of single and multiple application of topical CLDM-T 1% and 2% was investigated in healthy adult male volunteers. 1 subject given a single dose of CLDM-T 2% complained of headache as a subjective symptom, but the investigator judged this event to be unrelated with the study drug. Transient elevation of TG level was noted in 2 subjects in the multiple dose study(1 each in the CLDM-T 1% and 2% groups). The causal relationship of those events with the study drug was unknown. There was no other abnormality in dermatological finding, subjective symptom or objective medical finding. Plasma levels following single and multiple application of CLDM-T 1% and 2% were very low, and the excretion volume in urine was also minimal. Plasma levels reached a steady state 2 days after start of multiple application and gradually decreased after removal of the drug. According to the above results, it was confirmed that CLDM-T 1% and 2% are highly safe when it is applied as a single dose and multiple doses. (author abst.) |
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