NCT01354782已完成1 期
An Open, Single Centre, Single and Repeated Dose Study to Investigate the Pharmacokinetic Profile of Roflumilast and Roflumilast N-oxide After Administration of 500 μg Dose of Roflumilast in Healthy Chinese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetic profiles after single and repeated dose of roflumilast 500 µg administered to healthy Chinese subjects.
研究概览
简要总结
The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast 500 μg in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and female (24 male and 8 female) subjects of Chinese ethnic origin, age 40 years and older.
- •Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results.
- •Body weight according to a Body Mass Index (BMI) between 19 and 28 kg/[m²], (both inclusive) and a body weight ≥ 50 kg.
- •Females with childbearing potential who are using medically acceptable and reliable method of contraception for the entire study duration, such as tubal ligation, hysterectomy, intrauterine device without hormones or post-menopausal females, the latter is defined as females who have had no menstrual period for at least 2 years.
排除标准
- •History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food
- •History of allergic reactions to roflumilast or any inactive ingredients of the trial medication
- •History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease (within the last 2 years)
- •History of malignancy within the past 5 years
- •Electrocardiogram (ECG) abnormalities of clinical relevance (e.g. QTc according to Bazett's formula: QTc > 450 msec (male), QTc > 470 msec (female), PQ ≥ 220 msec)
- •Blood pressure ≥ 140 mm HG systolic or ≥ 90 mm HG diastolic
- •Elevated transaminases > 2 x upper Limit of normal range and or increased of the total bilirubin > 1.5 upper Limit of normal range
- •Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables
- •Chronic or clinically relevant acute infections
- •Proneness to orthostatic dysregulation, faintings, or blackouts
- •Positive results in any of the virology tests of acute or chronic infectious HIV and hepatitis A, B, and C virus infections
- •Positive drug screen
- •Abuse of alcohol or drugs
- •Positive β-HCG pregnancy test (female)
- •Pregnant or lactating females
研究组 & 干预措施
Roflumilast
Experimental
(This is a pharmacokinetic study)
干预措施: Roflumilast (Drug)
结局指标
主要结局
To determine the pharmacokinetic profiles after single and repeated dose of roflumilast 500 µg administered to healthy Chinese subjects.
时间窗: Period I: single dose, PK-Investigation over 8 days, Period II: repeated dose for 14 days, PK-Investigation on days 14 and 15
PK samples at pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h and 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h post dose after single dose and at the time points pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h and 24h after administration of a repeated dose
次要结局
- The safety and tolerability of single and repeated dose roflumilast 500 µg will be evaluated in terms of adverse event, ECG, blood pressure, pulse rate, and clinical laboratory tests.(During screening, clinical part and final check)
研究者
研究点 (1)
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