NL-OMON46632已完成不适用
A randomized, single-site, open-label, 2-way crossover, single-dose Phase I clinical trial to assess the bioequivalence of 2 tablets of a tapentadol 25 mg prolonged-release tablet formulation and 1 tablet of a tapentadol 50 mg prolonged-release tablet formulation in healthy male subjects under fed conditions - BE Tapentadol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Healthy male subjects
- •-18-55 yrs, inclusive
- •-BMI: 20.0-28.0 kg/m2, inclusive, with a body weight of no less than 50 kg.
- •-non-smoking or light-smoking
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 30 days from the start of the study. In case of donating more than 500 ml of blood in the 3 months prior the start of this study.;Evidence or history of alcohol or drug abuse including positive or missing alcohol urine test or
- •drugs of abuse test.
研究者
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