Comparison of Two Formulations of Androxal



Status:Completed
Healthy:No
Age Range:18 - 60
Updated:10/14/2017
Start Date:December 2013
End Date:December 2013

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A DOUBLE-BLIND CROSSOVER STUDY IN HEALTHY VOLUNTEERS TO COMPARE TWO FORMULATIONS OF ANDROXAL

To determine and compare the pharmacokinetics (PK) of a single dose of each of two
formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to
determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25
mg Androxal administered to healthy male volunteers.


Inclusion Criteria:

- Speaks, reads, and understands English or Spanish and is willing and able to provide
written informed consent on an Institutional Review Board (IRB)-approved form prior to
the initiation of any study procedures;

- Male, between the ages of 18-60 years;

- No significant abnormal findings at the screening physical examination as evaluated by
the Investigator;

- Normal laboratory values (or abnormal but not clinically significant) at screening as
determined by the Investigator;

- Subject is willing to remain in the clinic overnight for the Day 1 and Day 6 visits;

- Must be able to swallow gelatin capsules

Exclusion Criteria:

- Known hypersensitivity to Clomid;

- Abnormal screening visit vital signs or clinical laboratory evaluation considered
clinically significant by the Investigator;

- Subject with a significant organ abnormality or disease as determined by the
Investigator;

- Any medical condition that would interfere with the study as determined by the
Investigator;

- Slow Cytochrome P4502D6 (CYP2D6) metabolizer

- Participation in a clinical trial with investigational medication within 30 days prior
to study medication administration;

- An acute illness within 5 days of study medication administration;;

- A mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study and/or evidence of an uncooperative attitude, as
determined by the Investigator;

- History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary
embolism);

- History of myocardial infarction, unstable angina, symptomatic heart failure,
ventricular dysrhythmia, or known history of (corrected QT)QTc interval prolongation;

- An employee or family member of an employee of the study site or the Sponsor.
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