NCT02110368

Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions

An Open-Label, Randomized, Balanced, Single-Dose, Two Treatment, Four Period, Two Sequence Replicate Design, Bioequivalence Study Of Testosterone Topical Gel, 1.62% Metered Pump, Manufactured By Amneal Pharmaceuticals LLC With AndroGel (Testosterone Gel) 1.62% Metered-Dose Pump, Marketed By Abbvie Inc., In Testosterone-Deficient (Hypogonadal) Adult Male Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.

Detailed description

To compare the rate and extent of testosterone absorption for a test formulation of Testosterone Topical Gel, 1.62% Metered Pump, manufactured with that of AndroGel® (testosterone gel) 1.62% Metered-Dose Pump, in normal, healthy, adult, testosterone-deficient (hypogonadal) human male subjects under fasting conditions.

Conditions

• Primary Hypogonadism
• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone Topical Gel, 1.62% Metered Pump
DRUG	AndroGel (testosterone gel) 1.62% Metered-Dose Pump

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-03-01
• Completion: 2014-05-01
• First posted: 2014-04-10
• Last updated: 2014-06-26

Locations

1 site across 1 country: United States