JPRN-jRCT1080223420已完成1 期
Bioequivalence of DS-5058b (extended-release tablet) to oxycodone hydrochloride hydrate in healthy Japanese subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
The ratio of geometric least-square means and 90% CI for Cmax and AUCt were within the bioequivalence criteria (0.80-1.25) under both fasting and fed conditions. Therefore, DS-5058b (extended-release tablet) was judged to be bioequivalent to the reference drug. There was no meaningful difference in TEAE between 10 mg DS-5058b (extended-release tablet) and reference drug under both fasting and fed conditions, and no safety concern was noted in single oral administration of both drugs.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •Male Japanese
- •- Between the age of 20 and 45
- •- Between the BMI of 18.5 and 24.9
排除标准
- •- Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug.
- •- Presence or history of drug or alcohol dependence, etc.
研究者
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