To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
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
Clinical Pharmacology of miami
Miami, Florida, United States
Androxal Cmax Formulation A
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Time frame: 24 hours
Androxal Cmax Formulation B
To determine and compare the PK parameter Cmax between two formulations of Androxal
Time frame: 24 hours
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Single dose of 25 mg Androxal formulation B