A Single-Dose, Open-Label, Randomized, Four-Way Crossover Study to Assess the Dose-Proportionality of the Pharmacokinetics of Tapentadol, Given as Tamper-Resistant Tablets, in Healthy Japanese and Korean Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2
研究概览
简要总结
The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.
详细描述
This is a single-dose, open-label, single-center, randomized, four-way crossover study, ie, participants and investigator know the identity of the drug, which is assigned by chance, like flipping a coin, and participants may receive different interventions sequentially during the study. The study will consist of 4 treatment periods. A single dose of tapentadol (CG5503) will be administered orally with 240 mL of water under fasted conditions. All participants will receive 1 of the following 4 oral treatments in each period.
Treatment A: One 25-mg tablet (25 mg) of tapentadol (CG5503) Treatment B: One 50-mg tablet (50 mg) of tapentadol (CG5503) Treatment C: One 100-mg tablet (100 mg) of tapentadol (CG5503) Treatment D: Two 100-mg tablets (200 mg) of tapentadol (CG5503) Each period will be separated by 7 - 14 days.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese and Korean male volunteers, inclusive
- •Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg
- •Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and paternal grandparents are Japanese.
- •Korean volunteers must have resided outside of Korea for no more than 5 years and their parents and maternal and paternal grandparents are Korean.
排除标准
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease
- •History of hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities
- •History of significant pulmonary disease, including bronchospastic respiratory disease
- •History of diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol-acetaminophen, within 14 days before the first dose of the study drug is scheduled
- •History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
研究组 & 干预措施
001
tapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose
干预措施: tapentadol (CG5503) ER 25-mg TRF (Drug)
002
tapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose
干预措施: tapentadol (CG5503) ER 50-mg TRF (Drug)
003
tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose
干预措施: tapentadol (CG5503) ER 100-mg TRF (Drug)
004
tapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose
干预措施: tapentadol (CG5503) ER two 100-mg TRF (Drug)
结局指标
主要结局
Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2
时间窗: Two days
次要结局
- Number of participants with adverse events(Time of screening to end of treatment (up to 9.5 weeks))