Hypogonadotropic Hypogonadism, Primary Hypogonadism
Conditions
Brief 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.
Interventions
DRUGTestosterone Topical Gel, 1.62% Metered Pump
DRUGAndroGel (testosterone gel) 1.62% Metered-Dose Pump
Sponsors
Phase One Solutions, Inc.
Amneal Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | 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. |
| AUC0-inf | 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 |
| Cmax | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Time at which Cmax is first observed |
| 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 | Apparent first order terminal elimination rate constant determined from the terminal log-linear concentration-time data |
| 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 | Terminal elimination half-life |
Countries
United States
Outcome results
None listed