Phase I Clinical Study of SND919 (Pramipexole) Tablets. 1. Single Dose Study.
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Accession number;03A0186281
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| Title;Phase I Clinical Study of SND919 (Pramipexole) Tablets. 1. Single Dose Study. |
| Author;
IRIE SHIN
(Soseikai Kyushurinshoyakurise)
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.149-161(2003)
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| Figure&Table&Reference;FIG.6, TBL.7, REF.13 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The safety and pharmacokinetics of SND919 (pramipexole) at single dose administration were investigated in 10 healthy male volunteers (8: active drug, 2: placebo) as a clinical Phase I study. 0.1 mg of SND919 was administered as an initial dose and after the drug's safety was confirmed, the dosage was increased to the next higher dose (0.2 mg and 0.3 mg). No subjective and objective symptoms were observed with 0.1 mg. With 0.2 mg, 4 of the 8 subjects experienced mild somnolence (3 cases) or mild postural dizziness (1 case). With 0.3 mg, 5 of the 8 subjects experienced mild somnolence (2 cases), mild to moderate cold sweat (2 cases) or nausea (2 cases), moderate dizziness (1 case) or facial pallor (1 case), or mild light-headed (1 case). All these symptoms disappeared within several minutes to 3 hours after onset. Regarding vital signs, no clinically significant abnormal changes 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. Decrease in blood prolactin levels and increase in growth hormone levels, which considered to reflect the pharmacological action of SND919, were observed. The plasma concentration of unchanged drug after a single dose administration of 0.1, 0.2 or 0.3 mg reached Cmax at about 1-2 hours after administration and then decreased with a half-life of about 7 hours. Cmax and AUC increased dose-linearly. About 74% of the dose were excreted in urine by 24 hours after administration. It is concluded that a single dose administration of SND919 at doses up to 0.2 mg were unproblematic in regard to safety in the present study. (author abst.) |
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