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A Pilot Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions


N/A
18 Years
55 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Pilot Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions


Inclusion Criteria:



- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening

Exclusion Criteria:

- Positive test for HIV, Hepatitis B, or Hepatitis C.

- Treatment with known enzyme altering drugs.

- History of allergic or adverse response to exemestane or any comparable or similar
product.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

bioequivalence determined by statistical comparison Cmax

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Dennis N Morrison, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bio-Kinetic Clinical Applications, Inc.

Authority:

United States: Institutional Review Board

Study ID:

EXEM-03

NCT ID:

NCT01331447

Start Date:

May 2004

Completion Date:

May 2004

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

BioKinetic Clinical Applications, Inc.Springfield, Missouri  65802