Phase I Clinical Study of SS320A. (2). A Repeated Oral Administration Study.
|
Accession number;02A0208989
|
| Title;Phase I Clinical Study of SS320A. (2). A Repeated Oral Administration Study. |
| Author;
SEKINO HISAYUKI
(Sekino Byoin)
NOMURA MASAOMI
(Sekino Kenkyusho)
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.)
KIYOHARA CHIKAKO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
MARUYAMA YOKO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
OIKAWA TAKAYUKI
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.18;NO.1;PAGE.15-24(2002)
|
| Figure&Table&Reference;FIG.4, TBL.6, REF.2 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A Phase I Clinical Study of repeated dosages of SS320A was carried out in healthy adult male volunteers. SS320A was given 2 doses (6mg and 3mg/day, divided into 3) for 6 days. 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) In laboratory tests (hematology, biochemistry, and urinalysis), 2 subjects in the 6 g group showed increases in transaminase activities, which were judged to be Unknown Causality and Probably Related to the test drug, respectively. One subject in the 3g group also showed a slight increase in GPT activities level, where causality with the test drug was judged unknown. 3) In both of the 6g and 3g groups, pharmacokinetics of SS320A reached a steady state by Day 3. Accumulation was considered to be minor. 4) In both of the 6g and 3g groups, urinary excretion showed that changes in metabolism and excretion were minor. (author abst.) |
|
|
|
Related Articles;
|
|
