Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

NCT ID: NCT01331447

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-05-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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exemestane

25 mg tablet

Intervention Type DRUG

Other Intervention Names

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AROMASIN

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Roxane Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Roxane Laboratories, Inc.

Principal Investigators

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Dennis N Morrison, D.O.

Role: PRINCIPAL_INVESTIGATOR

Bio-Kinetic Clinical Applications, Inc.

Locations

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BioKinetic Clinical Applications, Inc.

Springfield, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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EXEM-03

Identifier Type: -

Identifier Source: org_study_id

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