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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

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ClinicalTrials.gov Identifier: NCT02110368
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : June 26, 2014
Sponsor:
Collaborator:
Phase One Solutions, Inc.
Information provided by (Responsible Party):
Amneal Pharmaceuticals, LLC

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

Condition or disease Intervention/treatment Phase
Primary Hypogonadism Hypogonadotropic Hypogonadism Drug: Testosterone Topical Gel, 1.62% Metered Pump Drug: AndroGel (testosterone gel) 1.62% Metered-Dose Pump Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014


Arm Intervention/treatment
Active Comparator: AndroGel
AndroGel (testosterone gel) 1.62% Metered-Dose Pump. One actuation 20.25 mg
Drug: AndroGel (testosterone gel) 1.62% Metered-Dose Pump
Experimental: Testosterone Gel
Testosterone Topical Gel, 1.62% Metered Pump. One actuation of 20.25 mg.
Drug: Testosterone Topical Gel, 1.62% Metered Pump



Primary Outcome Measures :
  1. AUC0-t [ Time Frame: 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 ]
    Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration.

  2. AUC0-inf [ Time Frame: 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 ]
    Area under the concentration vs. time curve, from time of first dosing to infinity

  3. Cmax [ Time Frame: 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 ]
    Maximum reported concentration. Estimated for both baseline


Secondary Outcome Measures :
  1. Tmax [ Time Frame: 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 ]
    Time at which Cmax is first observed

  2. Kel [ Time Frame: 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 ]
    Apparent first order terminal elimination rate constant determined from the terminal log-linear concentration-time data

  3. T 1/2 [ Time Frame: 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 ]
    Terminal elimination half-life



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy adult men with hypogonadism with testosterone levels <250ng/dL
  • 18 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.

Exclusion Criteria:

  • 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.
  • Has been treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates, phenothiazine, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that may impact subject safety or the validity of the study results.
  • Has positive cotinine test and/or smoked or used tobacco products within 60 days prior to the first dose of study medication
  • Has a positive urine screen for drugs of abuse
  • Has positive alcohol breathalyzer test
  • Has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus (HIV) at screening or has been previously treated for Hepatitis B, Hepatitis C, or HIV infection.
  • Any difficulty fasting or has any dietary restrictions such as lactose intolerance, vegan, low-fat, etc.
  • Unavailable for any confinement days or scheduled visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110368


Locations
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United States, Florida
Phase One Solutions, Inc.
Miami Gardens, Florida, United States, 33169
Sponsors and Collaborators
Amneal Pharmaceuticals, LLC
Phase One Solutions, Inc.
Investigators
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Principal Investigator: Lawrence Galitz, MD Phae 1 Solutions

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Responsible Party: Amneal Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02110368     History of Changes
Other Study ID Numbers: AL1401
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents