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Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations


N/A
40 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations


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.

Inclusion 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])

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Paul J. Limburg, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000473167

NCT ID:

NCT00343629

Start Date:

April 2006

Completion Date:

October 2007

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905