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 |
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.
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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