A Randomized, Open Label, Cross-over, Phase 1 Trial to Investigate the Pharmacokinetics in Multi-dose and the Food Effect in Single-dose of Pelubiprofen IR and Pelubiprofen SR in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- (Part1) Cmax,ss of Pelubiprofen IR (Pelubiprofen 30mg)
研究概览
简要总结
Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR (Pelubiprofen 45 mg) in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult healthy males aged 20~40 years
- •BMI valued over 19 kg/m2, below 27 kg/m2
- •Subjects whose blood pressure ; systolic BP over 90mmHg below 140mmHg, diastolic BP over 60mmHg below 90mmHg, stable station pulse over 45 bpm below 100 bpm
- •Subjects who agree with double protective contraception or able to certificate already sterilization operation 1 day before administration of Investigational new drugs within 14 days after completion
- •Subjects who voluntarily agreed with written consent
排除标准
- •Subjects with clinically significant disease or past medical history in hepatic, renal, GI tract, respiratory, musculoskeletal, endocrine, neuropsychiatry, blood tumor and cardiovascular system
- •Subjects with GI tract disease (eg. Crohn's disease, peptic ulcer etc.) or surgery (except appendectomy and herniotomy) influence on administration Investigational new drugs
- •Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID anti-inflammatory agents and antibiotics) including Pelubiprofen and Food
研究组 & 干预措施
Pelubiprofen SR (Pelubiprofen 45 mg)
干预措施: Pelubiprofen SR (Pelubiprofen 45 mg) BID (Drug)
Pelubiprofen IR (Pelubiprofen 30 mg)
干预措施: Pelubiprofen IR (Pelubiprofen 30mg) TID (Drug)
Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition
干预措施: Pelubiprofen SR (Pelubiprofen 45 mg) BID (Drug)
Pelubiprofen SR (Pelubiprofen 45 mg) fed condition
干预措施: Pelubiprofen SR (Pelubiprofen 45 mg) BID (Drug)
结局指标
主要结局
(Part1) Cmax,ss of Pelubiprofen IR (Pelubiprofen 30mg)
时间窗: 0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times)
(Part1) Cmax,ss of Pelubiprofen SR (Pelubiprofen 45 mg)
时间窗: 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times)
(Part1) Dose normalized AUCτ,ss of Pelubiprofen IR (Pelubiprofen 30mg)
时间窗: 0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times)
(Part1) Dose normalized AUCτ,ss of Pelubiprofen SR (Pelubiprofen 45 mg)
时间窗: 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times)
(Part2) Cmax of Pelubiprofen IR (Pelubiprofen 30mg)
时间窗: 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)
(Part2) Cmax of Pelubiprofen SR (Pelubiprofen 45 mg)
时间窗: 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)
(Part2) AUClast of Pelubiprofen IR (Pelubiprofen 30mg)
时间窗: 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)
(Part2) AUClast of Pelubiprofen SR (Pelubiprofen 45 mg)
时间窗: 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times)
次要结局
未报告次要终点