Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: sulindac (Drug); pharmacological study (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Paul J. Limburg, MD, MPH, Study Chair, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations
Study design: Prevention, Randomized
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.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Healthy volunteer
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Hemoglobin ≥ 12. 0 g/dL (women)
- Hemoglobin ≥ 13. 5 g/dL (men)
- WBC > 3,000/mm³
- Platelet count > 100,000/mm³
- Absolute neutrophil count > 1,500/mm³
- Alkaline phosphatase ≤ 1. 5 times upper limit of normal (ULN)
- Bilirubin ≤ 1. 5 times ULN
- ALT ≤ 1. 5 times ULN
- Creatinine ≤ 1. 5 times ULN OR creatinine clearance ≥ 30 mL/min
- No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs,
including aspirin-sensitive asthma or urticaria
- No condition that interferes with ingestion or absorption of oral medications
- No cancer within the past 3 years except nonmelanomatous skin cancer, localized
prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that
was previously treated > 6 months ago
- No uncontrolled concurrent illness including, but not limited to, the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction in the past 6 months
- Chronic renal disease
- Chronic liver disease
- Hypertension that is difficult to control
- Psychiatric illness or social situations that would limit study compliance
- No other significant clinical disorder or laboratory finding that would preclude study
participation
- No consumption of alcoholic or caffeinated beverages for ≥ 24 hours prior to study
drug administration and until all blood samples have been drawn
- Willing to provide required biologic specimens
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior investigational agents
- More than 6 months since prior regular use of (defined as a frequency of 7 consecutive
days for > 3 weeks or > 21 days total) or other concurrent nonsteroidal
anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors including, but
not limited to, the following:
- Ibuprofen
- Ketoprofen
- Naproxen
- More than 6 weeks since prior oral corticosteroids
- More than 30 days since prior and no concurrent use of any of the following:
- Methotrexate
- Corticosteroids
- Warfarin
- Ticlopidine
- Clopidogrel
- Low molecular weight heparins
- Abciximab
- Dipyridamole
- Eptifibatide
- Tirofiban
- Lithium
- Cyclosporine
- Hydralazine
- Angiotensin-converting enzymes (ACE) inhibitors
- ACE-receptor antagonists allowed
- Angiotensin-receptor blockers
- Ginkgo
- Ketorolac
- Levofloxacin
- Loop diuretics
- Meadowsweet
- Selective serotonin reuptake inhibitors
- Danaparoid
- No concurrent regular aspirin use unless prescribed by a physician for prevention
- A maximum of one aspirin (81 mg/day) allowed
- No concurrent herbal products (e. g., saw palmetto or Hypericum perforatum [St. John's
wort])
Locations and Contacts
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 2006
Last updated: May 23, 2008
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