Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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. OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 treatment arms. Arm I: Participants receive one sulindac capsule followed 7-10 days later by one sulindac tablet. Arm II: Participants receive one sulindac tablet followed 7-10 days later by one sulindac capsule. Blood is collected periodically during treatment for pharmacokinetic studies. After completion of study therapy, participants are followed at 7-10 days. PROJECTED ACCRUAL: A total of 28 participants will be accrued for this study.

Official Title
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Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: sulindac
* Other: pharmacological study


Participation Criteria
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Eligibility Criteria
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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 Naproxen 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 Warfarin Ticlopidine Clopidogrel Low molecular weight heparins Abciximab Dipyridamole Eptifibatide Tirofiban Lithium Cyclosporine Hydralazine Angiotensin-converting enzymes (ACE) inhibitors ACE-receptor antagonists allowed Angiotensin-receptor blockers Ginkgo Ketorolac Levofloxacin Loop diuretics Meadowsweet Selective serotonin reuptake inhibitors Danaparoid No concurrent regular aspirin use unless prescribed by a physician for prevention A maximum of one aspirin (81 mg/day) allowed No concurrent herbal products (e.g., saw palmetto or Hypericum perforatum [St. John's wort])

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sulindac|nan|
|Other: pharmacological study|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific