Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions

Roxane Laboratories

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: exemestane

Study type: Interventional

Funder types: Industry

Identifiers

NCT01331434

EXEM-02

Details and patient eligibility

About

The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions.

Enrollment: 47 patients

Sex: Female

Ages: 18 to 55 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 exemestane or any comparable or similar product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)