Comparison of Two Formulations of Androxal

Study Overview
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Brief Summary
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To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

Detailed Description
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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.

Official Title
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A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: 12.5 mg Androxal Formulation A
* Drug: 12.5 mg Androxal Formulation B
* Drug: 25 mg Androxal Formulation A
* Drug: 25 mg Androxal Formulation B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12.5 mg Androxal (formulations A and B)<br>12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation | Drug: 12.5 mg Androxal Formulation A<br>* Single dose of 12.5 mg Androxal formulation A<br>* Other names: enclomiphene citrate;Drug: 12.5 mg Androxal Formulation B<br>* Single dose of 12.5 mg Androxal Formulation B<br>* Other names: enclomiphene citrate;|
| Experimental: 25 mg Androxal (formulations A and B)<br>25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation | Drug: 25 mg Androxal Formulation A<br>* Single dose of 25 mg Androxal formulation A<br>* Other names: enclomiphene citrate;Drug: 25 mg Androxal Formulation B<br>* Single dose of 25 mg Androxal formulation B<br>* Other names: enclomiphene citrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androxal Cmax Formulation A | To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal | 24 hours | 
| Androxal Cmax Formulation B | To determine and compare the PK parameter Cmax between two formulations of Androxal | 24 hours |