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

NCT01760980 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-07-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01760980 on ClinicalTrials.gov