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

NCT02110368 | Completed Phase 3 DMC

• 1 other identifier: AL1401
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Hypogonadism; Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (3)

• AUC0-t

  Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration.

  Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours

• AUC0-inf

  Area under the concentration vs. time curve, from time of first dosing to infinity

  Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours

• Cmax

  Maximum reported concentration. Estimated for both baseline

  Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours

Secondary Outcomes (3)

• Tmax

  Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours

• Kel

  Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours

• T 1/2

  Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours

Study Arms (2)

AndroGel

ACTIVE COMPARATOR

AndroGel (testosterone gel) 1.62% Metered-Dose Pump. One actuation 20.25 mg

Drug: AndroGel (testosterone gel) 1.62% Metered-Dose Pump

Testosterone Gel

EXPERIMENTAL

Testosterone Topical Gel, 1.62% Metered Pump. One actuation of 20.25 mg.

Drug: Testosterone Topical Gel, 1.62% Metered Pump

Interventions

Testosterone Topical Gel, 1.62% Metered Pump DRUG

Testosterone Gel

AndroGel (testosterone gel) 1.62% Metered-Dose Pump DRUG

AndroGel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult men with hypogonadism with testosterone levels \<250ng/dL
• to 65 years of age (inclusive)
• Have normal PSA \< 4.0ng/mL
• Weighing a minimum of 50 kg and having a body mass index between 18.0 and 38.0 kg/m2.
• Good health as determined by medical history and lack of clinically significant abnormalities (other than hypogonadism).
• Vital signs, must be within the following ranges heart rate: 45-100 bpm; systolic BP: 90-150 mmHg; diastolic BP: 50-90 mmHg. Out-of-range vital signs may be repeated.

You may not qualify if:

• Is female
• History of allergy or sensitivity to AndroGel® or any component of drug or a related testosterone drug, Axiron®, Testim®, etc.
• History of allergy or intolerance to soy, soybean, and/or soy lecithin
• History of any drug or food hypersensitivity or intolerance which, would compromise the safety of the subject or the study.
• History or presence of clinically significant ocular, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any othercondition that, would jeopardize the safety of the subject or the validity of the study results.
• Had no major surgery or illness within 3 months before screening.
• History or presence of benign prostate hypertrophy, prostate and/or breast cancer.
• Has tattooed, damaged, scarred skin or any skin condition on right or left upper arm and shoulder region that may affect absorption of drug.
• Has a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory results at screening.
• Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
• Has donated blood within 56 days or plasma within 30 days prior to the first dose of study medication.
• Has participated in another clinical trial within 30 days prior to the first dose of study medication.
• Has used any over-the-counter medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
• Has used any prescription medication including hormonal treatment and or supplement within 30 days prior to the first dose of study medication.
• No depot injections or drug implants within 3 months of first dose of study medication.

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead
• Phase One Solutions, Inc.: collaborator

Study Sites (1)

Phase One Solutions, Inc.

Miami Gardens, Florida, 33169, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lawrence Galitz, MD

  Phae 1 Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

US (1)