Parallel, Group, Laboratory-Blinded, Single and Multiple-dose Pharmacokinetic Study of Ondansetron Administered as the Immediate-Release (Zofran) and Modified-Release (EUR1025) Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.
研究概览
简要总结
The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.
详细描述
The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers
- •Non- or ex-smokers
- •At least 21 years of age but not older than 55 years
- •Body mass index targeted to be at least 18.5 and less than 30 kg/m
- •Acceptable lab tests
- •Normal 12 lead ECG
- •Negative human chorionic gonadotropin (hCG) for females.
排除标准
- •No known hypersensitivity to Ondansetron or any related products
- •No presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption
- •No presence of significant heart disease or disorder discovered on screening ECG
- •Not pregnant
- •No alcohol or drug abuse history
- •No use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP)
- •No previous Investigational Product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study
研究组 & 干预措施
Regime 1
Regime 1 will be orally administered once daily in the morning over 6 consecutive days.
干预措施: EUR-1025 (Drug)
Regime 2
Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days
干预措施: EUR-1025 (Drug)
Regime 3
Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days.
干预措施: EUR-1025 (Drug)
Regime 4
Regime 4- Day 1- a single dose will be given. Day 2- one placebo capsule; Day 3- a single dose will be given . Day 4 & 5- two placebo capsules on each day; Day 6- a single does will be given.
干预措施: EUR-1025 (Drug)
结局指标
主要结局
Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.
时间窗: 6 days
次要结局
未报告次要终点