Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

Roxane Laboratories

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: letrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367626

LETR-T25-PVFD-1

Details and patient eligibility

About

The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

letrozole

Active Comparator group

Description:

2.5 mg tablet

Treatment:

Drug: letrozole

Drug: letrozole

Fermara

Active Comparator group

Description:

2.5 mg tablet

Treatment:

Drug: letrozole

Drug: letrozole