Comparison of Two Formulations of Androxal

Bioequivalence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984398
• Other study ID #: ZA-110
• Status: Completed
• Phase: Phase 1
• Start date: December 31, 2013
• Est. completion date: December 31, 2013

Study information

• Verified date: May 2019
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2013
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

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.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• 12.5 mg Androxal Formulation A
Single dose of 12.5 mg Androxal formulation A
• 12.5 mg Androxal Formulation B
Single dose of 12.5 mg Androxal Formulation B
• 25 mg Androxal Formulation A
Single dose of 25 mg Androxal formulation A
• 25 mg Androxal Formulation B
Single dose of 25 mg Androxal formulation B

Locations

Country	Name	City	State
United States	Clinical Pharmacology of miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Androxal Cmax Formulation A	To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal	24 hours
Primary	Androxal Cmax Formulation B	To determine and compare the PK parameter Cmax between two formulations of Androxal	24 hours

External Links

•   Sponsor Corporate Website