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CompletedNCT01331447Updated Jan 23, 2018

Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

An interventional study of exemestane in Breast Cancer, sponsored by Roxane Laboratories. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Breast Cancer
03

In context

Lead sponsor

Roxane Laboratories is the lead sponsor of 98 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Interventions

  • Drugexemestane

    25 mg tablet

    Also known as: AROMASIN

06

What researchers measure

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: 21 days

07

Study locations

1 site
  • BioKinetic Clinical Applications, Inc.
    Springfield, Missouri 65802, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01331447
Lead sponsor
Roxane Laboratories
First posted
Apr 8, 2011
Start date
May 2004
Primary completion
May 2004
Completion
May 2004
Last update
Jan 23, 2018

Study contacts

Dennis N Morrison, D.O.
principal investigator · Bio-Kinetic Clinical Applications, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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