Phase I Clinical Study of SS320A. (4). Pharmacokinetics in the Elderly.
|
Accession number;02A0208991
|
| Title;Phase I Clinical Study of SS320A. (4). Pharmacokinetics in the Elderly. |
| Author;
NAKAMICHI NOBORU
(Jikei Univ. School of Medicine)
TSUBOI MINORU
(Enu・esukurinikku)
MORIYA KATSUHIRO
(SS Pharm. Co., Ltd.)
ITO OSAMU
(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.)
TAKAHASHI MASAMI
(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.45-52(2002)
|
| Figure&Table&Reference;FIG.4, TBL.5, REF.6 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To prepare indication expansion of SS320A in the elderly, SS320A was given once postprandially to healthy male volunteers aged at 65 years or older. 1) No notable changers were found in signs and symptoms, vital signs, or ECG findings. 2) No notable changers were found in laboratory data (hematology and biochemistry). Urinalysis showed some slight deviations from normal range, however, they were considered within physiological changes. There were no abnormal changes attributable to SS320A. 3) No significant differences were found in Cmax, Tmax, t1/2Z, AUC0-24, or AUC0-.INF. of unchanged SS320A in plasma between the elderly and non-elderly. 4) Cumulative urinary excretion rate until 36 hours after administration was low in the elderly, which was considered due to low excretion rate of metabolite M1. Decreased excretion function of the kidney in the elderly was considered a reason for low urinary excretion rate of metabolite M1. 5) In comparison with non-elderly, AUC0-.INF. of plasma metabolite Ml increased by 1.7 folds and t1/2Z was prolonged in the elderly, which were considered due to influence of decreased urinary excretion of metabolite M1. Changes in pharmacokinetics of metabolite M1 observed in the elderly were considered to have only slight influences on the efficacy or safety in clinical settings because changes in plasma metabolite M1 levels were low, no pharmacological effects of metabolite M1 was observed, and there were no safety problem. These results show that aging influence is observed in pharmacokinetics of metabolite M1, but not for unchanged SS320A. (author abst.) |
|
|
|
Related Articles;
|
|
