Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers
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.
Unspecified Adult Solid Tumor, Protocol Specific
Other: pharmacological study
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations|
|Study Start Date:||April 2006|
|Study Completion Date:||October 2007|
- Compare the systemic exposure of sulindac tablets vs sulindac capsules in healthy volunteers.
- 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.
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Paul J. Limburg, MD, MPH||Mayo Clinic|