NCT00343629

Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	sulindac
OTHER	pharmacological study

Timeline

• Start date: 2006-04-01
• Completion: 2007-10-01
• First posted: 2006-06-23
• Last updated: 2015-04-28

Locations

1 site across 1 country: United States