NL-OMON23562尚未招募不适用
A Prospective, Open-label, Two Arm Parallel Study in Men with Prostate Cancer to Investigate the Effect of Enzalutamide on the Pharmacokinetics (PK) of Oxycodone Following a Single 15 mg Oral Dose of Oxycodone Normal-Release
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
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
入选标准
- •? Males aged = 18 years;
- •? Diagnosed prostate cancer;
- •? Treated with enzalutamide 160 mg once daily for 40 days (arm 1)
排除标准
- •? known metastases in the liver that would affect drug metabolism;
- •? Child-Pugh classification B or C that would affect drug metabolism;
- •? known moderate-severe renal dysfunction (GFR <60 ml/min/1.73m2) that would affect drug metabolism;
- •? gastrointestinal disorders that would potentially alter absorption;
- •? previous gastric bypass or gastric band surgery;
- •? known allergy, hypersensitivity or intolerance to normal-release oxycodone;
- •? a history of drug abuse or treatment for abuse;
- •? dose-reduction or =5 successive days of treatment interruption of enzalutamide within 40 days prior to the study day (arm 1);
- •? treatment with enzalutamide within 40 days prior to the study day (arm 2);
- •? use of oxycodone normal-release within 24 hour prior to oxycodone intake or use of oxycodone extended-release within 2 days prior to oxycodone intake;
- •? use of other medication that would affect oxycodone metabolism, see section 5.2 and appendix B;
- •? use of other medication that would affect enzalutamide metabolism, see section 5.2 and appendix B (arm 1).
研究者
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