Comparison of Two Formulations of Androxal

Phase 1

Completed

Interventions: Drug: 12.5 mg Androxal Formulation A
Drug: 25 mg Androxal Formulation A
Drug: 12.5 mg Androxal Formulation B
Drug: 25 mg Androxal Formulation B

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
12.5 mg Androxal (formulations A and B)	12.5 mg Androxal Formulation A	12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
12.5 mg Androxal (formulations A and B)	12.5 mg Androxal Formulation B	12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
25 mg Androxal (formulations A and B)	25 mg Androxal Formulation A	25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
25 mg Androxal (formulations A and B)	25 mg Androxal Formulation B	25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation

Primary Outcome Measures

Name	Time	Method
Androxal Cmax Formulation B	24 hours	To determine and compare the PK parameter Cmax between two formulations of Androxal
Androxal Cmax Formulation A	24 hours	To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal

Secondary Outcome Measures