Conditions: Bioequivalence
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: yes

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.

Arms:
arm 1: 12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation arm 2: 25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation

Interventions: intervention 1: 12.5 mg Androxal Formulation A intervention 2: 12.5 mg Androxal Formulation B intervention 3: 25 mg Androxal Formulation A intervention 4: 25 mg Androxal Formulation B
Intervention descriptions: intervention 1: Single dose of 12.5 mg Androxal formulation A intervention 2: Single dose of 12.5 mg Androxal Formulation B intervention 3: Single dose of 25 mg Androxal formulation A intervention 4: Single dose of 25 mg Androxal formulation B

Protocol document: