NCT01760980

Pivotal Bioequivalence Study of Exemestane 25 mg Tablets Under Fasting Conditions in Healthy Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the bioequivalence of the test product, Exemestane 25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin® (exemestane) 25 mg tablets of Pharmacia \& Upjohn Company, Division of Pfizer Inc., New York, United States of America in healthy male and postmenopausal female subjects, under fasting conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Reference product (A) Aromasin (Exemestane)	Aromasin tablets will be administered under fasting conditions on two occasions
DRUG	Test product (B) Exemestane	Exemestane tablets will be administered under fasting conditions on one occasion

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-01-04
• Last updated: 2019-07-05

Locations

1 site across 1 country: South Africa