Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Prevention	Completed	40 and over	NCI	MAYO-03-1-BIO MAYO-CPN0576, MAY03-1-BIO, MAYO-05-004233, NCT00343629

Objectives

Primary

1. Compare the systemic exposure of sulindac tablets vs sulindac capsules in healthy volunteers.

Secondary

1. Compare the terminal half-life and time of peak drug concentration of sulindac tablets vs sulindac capsules.

Entry Criteria

Disease Characteristics:

• Healthy volunteer

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])

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

Expected Enrollment

A total of 28 participants will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Paul Limburg, MD, MPH, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations
Trial Start Date		2006-04-14
Registered in ClinicalTrials.gov		NCT00343629
Date Submitted to PDQ		2006-04-18
Information Last Verified		2006-12-10
NCI Grant/Contract Number		CN25000, CA15083

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