hase I Clinical Study of SS320A. (1). A Single Oral Administration Study.
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Accession number;02A0208988
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| Title;hase I Clinical Study of SS320A. (1). A Single Oral Administration Study. |
| Author;
TAKAHASHI NORIYUKI
(Kanamachimedikarukurinikku)
KOKITA TOSHIO
(SS Pharm. Co., Ltd.)
YANO KEN'ICHI
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
KAWASE ICHIRO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
MARUYAMA YOKO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
KIYOHARA CHIKAKO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
MITANI HIRONO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
ITO MASAYO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
OIKAWA TAKAYUKI
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
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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.18;NO.1;PAGE.7-14(2002)
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| Figure&Table&Reference;FIG.6, TBL.4, REF.7 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;SS320A at single doses of 2 g, 4 g, or 6 g was orally given to 5 healthy adult male volunteers in a Phase I Clinical Study. 1) No notable changers were found in physicians' consultation, signs and symptoms, vital signs (blood pressure, pulse rate, body temperature, and respiratory rate), ECG findings, or pulmonary function tests. 2) No notable changers were found in laboratory data (hematology, biochemistry, and urinalysis). 3) In pharmacokinetic evaluation, Cmax of plasma unchanged SS320A was 38.45, 78.54, and 109.90 .MU.g/mL in the 2, 4, and 6 g groups, respectively, Tmax was 0.8, 1.3, and 0.8 h, and t1/2Z was 3.3, 3.0, and 3.0 h, and AUC0-.INF. was 136.55,379.85,711.50 .MU.g h/mL. There were no significant differences in Tmax or t1/2Z between doses. 4) Mean rate of cumulative urinary excretion of unchanged SS320A until 36 hours after administration was 0.9, 1.6, and 2.0% in the 2, 4, and 6 g groups, respectively, and that of metabolite M1 was 44.6, 38.0, and 38.8%, respectively. In addition, total cumulative excretion rate until 36 hours including the unchanged SS320A and metabolite M1 was 45.5, 39.5, and 40.8%, respectively. These results show that single oral dose of SS320A up to 6 g is safe and tolerable. (author abst.) |
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