Phase I Clinical Study of SND919 (Pramipexole) Tablets. 2. Multiple Dose Study.
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Accession number;03A0186282
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| Title;Phase I Clinical Study of SND919 (Pramipexole) Tablets. 2. Multiple Dose Study. |
| Author;
IRIE SHIN
(Soseikai Kyushurinshoyakurikurinikku)
URAE AKINORI
(Soseikai Kyushurinshoyakurikurinikku)
URAE RYUJI
(Soseikai Kyushurinshoyakurikurinikku)
YOSHIGA HIROMU
(Soseikai Kyushurinshoyakurikurinikku)
TANAKA TAKANORI
(Soseikai Kyushurinshoyakurikurinikku)
SHA KOJI
(Nippon Boehringer Ingelheim Co., Ltd.)
KAGIMURA TATSUO
(Nippon Boehringer Ingelheim Co., Ltd.)
TARUI SACHIYO
(Nippon Boehringer Ingelheim Co., Ltd.)
AMAMOTO TOSHIAKI
(Soseikai)
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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.19;NO.2;PAGE.163-177(2003)
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| Figure&Table&Reference;FIG.5, TBL.5, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The safety and pharmacokinetics of SND919 (pramipexole) at multiple dose administration were investigated in 10 healthy male volunteers (8: active drug, 2: placebo) as a clinical Phase I study. The dosing period for the present study was set at 7 days. The study medication was started at 0.1mg * 1 time/day on day 1, and escalated to 0.1mg * 2 times/day on day 2, and to 0.1mg * 3 times/day on day 3-6 while confirming safety. 0.1mg * 1 time/day was administered on day 7. Five of the 8 subjects experienced mild somnolence (4 cases), moderate sickness (1 case), mild headache (1 case), sensation of heat (1 case) and fever (1 case), none of which, however, were serious. For all these symptoms except the sensation of heat and fever, a causal relationship could not be ruled out. In terms of weight, blood pressure, pulse rate, EEG, and ECG, no clinically significant abnormal changes related to SND919 were observed. In clinical laboratory test, slight deviations from reference values were observed. However, all these findings were considered to be within the range of physiological changes and to be clinically unproblematic. Decrease in blood prolactin levels and increase in blood growth hormone levels, which considered to reflect the pharmacological action of SND919 were observed. The plasma concentration of unchanged drug reached a plateau at 5th days of administration (at 3rd days of 0.1 mg * 3 times/day), with no major difference observed in the t1/2 values obtained after initial administration and final administration; there was no evidence for accumulation of the drug in the body. It was concluded that when SND919 was orally administered at multiple doses of up to 0.3 mg/day (3 divided portions) for 7 days, no problematic findings were obtained in terms of safety. (author abst.) |
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