NCT00343629已完成不适用
Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Giving healthy volunteers sulindac capsules or sulindac tablets may help doctors learn which form of the drug may be more effective in preventing cancer.
PURPOSE: This randomized clinical trial is studying sulindac capsules to see how well they work compared with sulindac tablets in healthy volunteers.
详细描述
OBJECTIVES:
Primary
- Compare the systemic exposure of sulindac tablets vs sulindac capsules in healthy volunteers.
Secondary
- Compare the terminal half-life and time of peak drug concentration of sulindac tablets vs sulindac capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •Healthy volunteer
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Hemoglobin ≥ 12.0 g/dL (women)
- •Hemoglobin ≥ 13.5 g/dL (men)
- •WBC > 3,000/mm³
- •Platelet count > 100,000/mm³
- •Absolute neutrophil count > 1,500/mm³
- •Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •ALT ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30 mL/min
- •No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
- •No condition that interferes with ingestion or absorption of oral medications
- •No cancer within the past 3 years except nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was previously treated > 6 months ago
- •No uncontrolled concurrent illness including, but not limited to, the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Myocardial infarction in the past 6 months
- •Chronic renal disease
- •Chronic liver disease
- •Hypertension that is difficult to control
- •Psychiatric illness or social situations that would limit study compliance
- •No other significant clinical disorder or laboratory finding that would preclude study participation
- •No consumption of alcoholic or caffeinated beverages for ≥ 24 hours prior to study drug administration and until all blood samples have been drawn
- •Willing to provide required biologic specimens
- •PRIOR CONCURRENT THERAPY:
- •More than 6 months since prior investigational agents
- •More than 6 months since prior regular use of (defined as a frequency of 7 consecutive days for > 3 weeks or > 21 days total) or other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors including, but not limited to, the following:
- •Ibuprofen
- •Ketoprofen
- •More than 6 weeks since prior oral corticosteroids
- •More than 30 days since prior and no concurrent use of any of the following:
- •Methotrexate
- •Corticosteroids
- •Ticlopidine
- •Clopidogrel
- •Low molecular weight heparins
- •Abciximab
- •Dipyridamole
- •Eptifibatide
- •Tirofiban
- •Cyclosporine
- •Hydralazine
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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