Comparison of Two Formulations of Androxal
Completed · Phase 1
Conditions studied: Bioequivalence
In brief
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
Key facts
- Study ID
- NCT01984398
- Run by
- Repros Therapeutics Inc.
- People needed
- 16
- Starts
- 2013-12-31
- Expected to finish
- 2013-12-31
- Last updated by the study team
- 2019-05-06
Who can join
Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Clinical Pharmacology of miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.