Phase I Clinical Study of SS320A. (3). Studies on Single Administration, Influence of Meals, and Repeated Administration.
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Accession number;02A0208990
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| Title;Phase I Clinical Study of SS320A. (3). Studies on Single Administration, Influence of Meals, and Repeated Administration. |
| Author;
SEKINO HISAYUKI
(Sekino Byoin)
NOMURA MASAOMI
(Sekino Kenkyusho)
MORIYA KATSUHIRO
(SS Pharm. Co., Ltd.)
ITO OSAMU
(SS Pharm. Co., Ltd.)
YANO KEN'ICHI
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
KOREMURA HIROYO
(SS Pharm. Co., Ltd., Cent. Res. Lab.)
KAWASE ICHIRO
(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.)
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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.25-43(2002)
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| Figure&Table&Reference;FIG.6, TBL.11, REF.6 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Since clinical dose of SS320A was decided to be 400 mg per dose, 3 times daily, influence of meals was examined in a cross-over method to healthy adult male volunteers, in which SS320A at 400 mg was given once during fasting or postprandially. Linearity was investigated after single administration at a dose of 800 mg during fasting. In addition, pharmacokinetic profile of repeated administration was investigated at the clinically recommended dose. 1) No notable changers were found in signs and symptoms, vital signs, ECG findings, or laboratory data in the single or repeated administration studies including port study examinations. 2) Postprandial Cmax and AUC0-.INF. decreased by approximately 44% and 12%, respectively, compared to those during fasting. Postprandial Tmax was delayed. M1 also showed a decrease in Cmax and delay of Tmax, confirming influence of meals in pharmacokinetics. 3) Cmax and AUC0-.INF. of unchanged SS320A showed a proportionality with dosages, ranging from 400 mg to 6 g and 400 mg to 2 g, respectively. 4) In the repeated administration study, mean plasma levels of unchanged SS320A were constant before morning administration on Day 3 and later. Cmax of unchanged SS320A and M1 showed no significant differences between Day 1 and final administration (16th administration). Urinary excretion rate per day including unchanged SS320A, metabolite M1 and M2 in the repeated administration period was constant in a period from Day 2 to Day 5. Metabolite M1 also showed a similar profile. Content rate of metabolite M1 in total excretion rate was constant, 86% to 89%, from Day 1 to Day 6. These studies suggest that, in the repeated administration study at the clinically recommended dose, pharmacokinetics reach a steady state by Day 3 with less changes and minor accumulation. (author abst.) |
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