NCT00905190已完成1 期
Single Dose Crossover Comparative Bioavailability Study To Assess the Effect of Food on the Pharmacokinetics of Ondansetron Modified-Release Capsules (EUR1025) in Healthy Male and Female Volunteers
Forest Laboratories1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2009年2月最近更新:
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
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Effects of food on the pharmacokinetics of a single 24 mg dose of ondansetron administered under fed and fasting conditions
研究概览
简要总结
This study is to assess the effect of food on a single dose of EUR-1025 when taken with a meal and taken on an empty stomach.
详细描述
The objective of this study is to assess the effect of food on the pharmacokinetics of a single 24 mg dose of EUR-1025 administered as a novel modified-release capsule formulation under fed and fasting conditions.
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
- 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,
- •Of at least 21 years of age but not older than 55 years with a body mass index targeted to be at least 18.5 and less than 30 kg/m2,
- •Healthy, normal lab values,
- •Negative HIV, Hepatitis B & C and a negative ethyl alcohol and drug screen,
- •Normal 12 lead ECG, negative human chorionic gonadotropin (hCG) for females.
排除标准
- •No known hypersensitivity to Ondansetron or any related products,
- •Presence of significant gastrointestinal, liver or kidney disease,or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects,
- •History of significant gastrointestinal, liver or kidney disease,
- •Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease,
- •Suicidal tendency,
- •History of or disposition to seizures, state of confusion, clinically relevant psychiatric disease,
- •Presence of significant heart disease or disorder discovered on screening ECG,
- •Females who are found to have a positive serum pregnancy test at screening or are nursing,
- •Females of childbearing potential who refuse to use an acceptable contraceptive regimen from the screening visit and throughout the study,
- •Maintenance therapy with any drug,
- •Significant history of drug dependency or alcohol abuse (> 2 units of alcohol per day, intake of excessive alcohol, acute or chronic),
- •Any clinically significant illness in the previous 28 days before day 1 of the study,
- •Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,fluconazole, ketoconazole,diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before day 1 of this study,
- •Volunteers who took an 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,
- •Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately,
- •Inability to understand and to observe the instructions of the physician,
- •Donation of 500 ml or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies) in the previous 56 days before day 1 of this study,
- •Positive urine screening of drugs or abuse,
- •Any history of tuberculosis and/or prophylaxis for tuberculosis,
- •Positive results to HIV, HBsAg, or anti-HCV tests,
- •No subjects will be allowed to enroll in this study more than once.
研究组 & 干预措施
Fed
Experimental
A single oral dose of ondansetron (1 x 24 mg) will be administered with approximately 240 ml of water in the morning. The ondansetron dose will be administered after a 10-hour overnight fast and thirty minutes after consuming a high-fat, high-caloric breakfast
干预措施: Ondansetron (Drug)
Fasting
Experimental
A single oral dose of ondansetron (1 x 24 mg) will be administered with approximately 240 ml of water in the morning after a 10-hour overnight fast.
干预措施: Ondansetron (Drug)
结局指标
主要结局
Effects of food on the pharmacokinetics of a single 24 mg dose of ondansetron administered under fed and fasting conditions
时间窗: 1 dose on two separate days
次要结局
未报告次要终点
研究者
研究点 (1)
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