Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal

Exclusion Criteria

• •1. Known hypersensitivity to Clomid;
• •2. Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
• •3. A hematocrit \>54% or a hemoglobin \>17 g/dL.
• •4. Subject with a significant organ abnormality or disease as determined by the Investigator;
• •5. Any medical condition that would interfere with the study as determined by the Investigator;
• •6. Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
• •7. An acute illness within 5 days of study medication administration;
• •8. Positive urine drug screen at the screening visit;
• •9. Known history of HIV and/or Hepatitis B or C
• •10. Tobacco (nicotine products) use in the 3 months prior to the study;
• •11. 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;
• •12. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
• •13. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
• •14. An employee or family member of an employee of the study site or the Sponsor;
• •15. Previous participation in a clinical study of Androxal.