Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343629
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2006-06-22
Brief Title:
Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers
Sponsor:
Mayo Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Bioequivalency Study of Sulindac in Capsule vs Tablet Formulations
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MAYO-05-004233 | None | None | None |
| MAYO-03-1-BIO | None | None | None |
| MAYO-CPN0576 | None | None | None |