Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00343629|
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : April 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: sulindac Other: pharmacological study||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Official Title:||Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations|
|Study Start Date :||April 2006|
|Actual Study Completion Date :||October 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343629
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Paul J. Limburg, MD, MPH||Mayo Clinic|