Drug-Drug Interaction Study to Assess the Effects of Steady-State Cardizem LA (Diltiazem Hydrochloride) and Steady-State Pitavastatin on Their Respective Pharmacokinetics in Healthy Adult Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- NK-104 AUC
研究概览
简要总结
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.
详细描述
Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
- •Subject has a body mass index of 18 to 30 kg/m2, inclusive.
- •Subject has normal hematology, serum chemistry, and urinalysis test results.
- •Subject is able and willing to abstain from alcohol, grapefruit-containing foods or beverages, caffeine, or caffeine-containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until after completion of this study.
- •Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until after study completion.
排除标准
- •Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
- •Subject has had a previous allergy or intolerance to treatment with pitavastatin, diltiazem, or any drugs in these classes.
- •Subject has a history of drug or alcohol abuse.
- •Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
研究组 & 干预措施
All Subjects
There was 1 treatment period, with each subject receiving a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15
干预措施: Pitavastatin (NK-104) (Drug)
All Subjects
There was 1 treatment period, with each subject receiving a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15
干预措施: Diltiazem (Cardizem LA) 240 mg QD (Drug)
结局指标
主要结局
NK-104 AUC
时间窗: 15 Days
次要结局
- Number of Participants With at Least One Adverse Event.(24 Days)