Phase I Clinical Study of SCH 18908 (Ribavirin), an Antiviral Agent. A Single Oral Administration Study in Healthy Adult Male Volunteers.
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Accession number;02A0429245
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| Title;Phase I Clinical Study of SCH 18908 (Ribavirin), an Antiviral Agent. A Single Oral Administration Study in Healthy Adult Male Volunteers. |
| Author;
FUKASE HIROYUKI
(Shipishikurinikku)
MIYASONO YUICHIRO
(Shipishikurinikku)
NAGATA RYOICHI
(Shipishikurinikku Rinshoyakuriken)
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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.4;PAGE.521-538(2002)
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| Figure&Table&Reference;FIG.4, TBL.9, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;SCH 18908 was administered orally as a single dose to 54 healthy male volunteers to examine its safety, tolerance and pharmacokinetics. The study consisted of six steps (I to VI), and a single dose of SCH 18908 at 200, 400, 600, 800, 1000, or 1200mg was given orally to 6 subjects and placebo to 3 subjects in each step. The subjects were randomly allocated to the groups. Mild headache was seen in 1 subject in the 1200mg group which disappeared without any treatment. Causal relationship to test drug administration was judged to be "possibly related"Temporal region pain was seen in 1 subject in the placebo group which was Judged to be "not related to the test drug". In abnormalities in laboratory data, high CPK values were found in 3 subjects in the 200mg group which were judged to be "not related" since it was thought to have occurred as a result of exercise after discharge from hospital. Occult hematuria and an increase in small-round epidermal cells were observed in 1 subject in the 1000mg group which was judged to be "unlikely related" because it was considered due to work requiring standing for a long duration. High glyceride was seen in 1 subject in the placebo group which was considered to be "not related." Vital signs and body weight changed within physiological range, and no abnormalities were found in ECG findings (standard 12 lead) and ophthalmology. Cmax of plasma SCH 18908 was 1.4 to 2.2 hours after administration with biphasic and slow elimination. Elimination half-life (t1/2.BETA.) was 28.3 to 48.7 hours. Linearity was seen with Cmax in the dose range of 200 to 800mg and with AUC0-t (AUC until the last determination time) from 200 to 1000mg. At doses higher than the above ranges, Cmax and AUC0-t plateaued, showing possible saturation in absorption. Apparent distribution volume (Vz/F) was large, 2144 to 3098L, showing high distribution to tissues. Cumulative urinary excretion rate was 7.71 to 15.9% of dose, showing no dose-dependent changes.... (author abst.) |
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