NCT00659074已完成1 期
Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 24 mg ODT With That of GlaxoSmithKine's Zofran 24 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rate and Extend of Absorption
研究概览
简要总结
Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT
详细描述
To Compare the single-dose bioavailability of Kali's Ondansetron 24 mg ODT with that of GlaxoSmithKine's Zofran 24 mg ODT under fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form(ICF) duly signed by the volunteer
- •Males and females aged between 18 and 55 years with a body mass index (BMI) greater or equal to 19 and below 30 kg/ m2
- •Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance(laboratory tests are presented in section 6.1.1.3)
- •Healthy according to the laboratory results and physical examination.
- •Non- or ex- smokers
排除标准
- •Significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- •Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- •Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
- •Females who are pregnant, lactating or are likely to become pregnant during the study phases.
- •Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body.
- •Positive pregnancy test before and during the study.
- •Maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease.
- •Any clinically significant illness in the previous 28 days before day 1 of this study.
- •Use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
- •Participation in another clinical trial in the previous 28 days before day 1 of this study.
- •Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
- •Positive urine screening of drugs of abuse (drug names are presented in section 7.1.4).
- •Positive results to HIV, HBsAg or anti-HCV tests.
研究组 & 干预措施
A
Experimental
Ondansetron ODT
干预措施: Ondansetron (Drug)
B
Active Comparator
Zofran ODT
干预措施: Zofran (Drug)
结局指标
主要结局
Rate and Extend of Absorption
时间窗: 24 Hours
次要结局
未报告次要终点
研究者
研究点 (1)
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