Comparison of Two Formulations of Androxal
Condition: Bioequivalence
Intervention: 12.5 mg Androxal Formulation A; 12.5 mg Androxal Formulation B; 25 mg Androxal Formulation A; 25 mg Androxal Formulation B
Intervention description: Single dose of 12.5 mg Androxal formulation A; Single dose of 12.5 mg Androxal Formulation B; Single dose of 25 mg Androxal formulation A; Single dose of 25 mg Androxal formulation B
Intervention MeSH terms: Citric Acid; Sodium Citrate; Enclomiphene; Clomiphene; Zuclomiphene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        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.