- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110368
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
June 25, 2014 updated by: Amneal Pharmaceuticals, LLC
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
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami Gardens, Florida, United States, 33169
- Phase One Solutions, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AndroGel
AndroGel (testosterone gel) 1.62% Metered-Dose Pump.
One actuation 20.25 mg
|
|
Experimental: Testosterone Gel
Testosterone Topical Gel, 1.62% Metered Pump.
One actuation of 20.25 mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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
|
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
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lawrence Galitz, MD, Phae 1 Solutions
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
April 8, 2014
First Submitted That Met QC Criteria
April 8, 2014
First Posted (Estimate)
April 10, 2014
Study Record Updates
Last Update Posted (Estimate)
June 26, 2014
Last Update Submitted That Met QC Criteria
June 25, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- AL1401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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