Bioequivalence
Conditions
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.
Interventions
DRUG12.5 mg Androxal Formulation A
Single dose of 12.5 mg Androxal formulation A
DRUG12.5 mg Androxal Formulation B
Single dose of 12.5 mg Androxal Formulation B
DRUG25 mg Androxal Formulation A
Single dose of 25 mg Androxal formulation A
DRUG25 mg Androxal Formulation B
Single dose of 25 mg Androxal formulation B
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Androxal Cmax Formulation A | 24 hours | To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal |
| Androxal Cmax Formulation B | 24 hours | To determine and compare the PK parameter Cmax between two formulations of Androxal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 12.5 mg Androxal (Formulations A and B) During Treatment Period 1, participants were randomly assigned to a single dose of either 12.5 mg Androxal Formulation A or 12.5 mg Androxal Formulation B.
After the washout period, participants then crossed over to receive the alternate 12.5 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B. | 8 |
| 25 mg Androxal (Formulations A and B) During Treatment Period 1, participants were randomly assigned to a single dose of either 25 mg Androxal formulation A or 25 mg Androxal formulation B.
After the washout period, participants then crossed over to receive the alternate 25 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | 12.5 mg Androxal (Formulations A and B) | 25 mg Androxal (Formulations A and B) | Total |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 7.5 | 37.8 years STANDARD_DEVIATION 6.1 | 37.7 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 8 | 0 / 8 | 1 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Androxal Cmax Formulation A
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Time frame: 24 hours
Population: Safety and PK populations are the same
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12.5 mg Androxal Formulation A | Androxal Cmax Formulation A | 0.999 ng/mL | Standard Deviation 0.349 |
| 25 mg Androxal Formulation A | Androxal Cmax Formulation A | 1.67 ng/mL | Standard Deviation 0.74 |
Primary
Androxal Cmax Formulation B
To determine and compare the PK parameter Cmax between two formulations of Androxal
Time frame: 24 hours
Population: Safety and PK populations are the same
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12.5 mg Androxal Formulation A | Androxal Cmax Formulation B | 1.08 ng/mL | Standard Deviation 0.42 |
| 25 mg Androxal Formulation A | Androxal Cmax Formulation B | 1.74 ng/mL | Standard Deviation 0.47 |