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A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions


N/A
18 Years
45 Years
Not Enrolling
Male
Breast Cancer

Thank you

Trial Information

A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed 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 letrozole 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:

31 days

Safety Issue:

No

Principal Investigator

Alan K Copa, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

PRAC Institute, Ltd.

Authority:

United States: Food and Drug Administration

Study ID:

LETR-T25-PVFD-1

NCT ID:

NCT01367626

Start Date:

March 2008

Completion Date:

April 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location
PRACS Institute, Ltd. Fargo, North Dakota  58104