Spots Global Cancer Trial Database for Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

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Trial Identification

Brief Title: Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

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

Study ID: NCT00343629

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

sulindac

pharmacological study

Study Description

Brief Summary: 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: 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.