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

NCT02110368 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-06-26

No results posted yet for this study

Summary

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

Conditions

  • Primary Hypogonadism
  • Hypogonadotropic Hypogonadism

Interventions

DRUG

Testosterone Topical Gel, 1.62% Metered Pump

DRUG

AndroGel (testosterone gel) 1.62% Metered-Dose Pump

Sponsors & Collaborators

  • Phase One Solutions, Inc.

    collaborator INDUSTRY

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Lawrence Galitz, MD · Phae 1 Solutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-03-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02110368 on ClinicalTrials.gov