Testosterone hydroxypropyl-ß-cyclodextrin (HPBCD), 1 mg and 2 mg tablets Not Applicable
Conditions
Interventions
The subjects were assigned to one sequence of treatments, e.g. T1/T2/T3 or T1/T3/T2 or T2/T1/T3 or T2/T3/T1 or T3/T1/T2 or T3/T2/T1 according to the randomisation number. Randomisation number was give
expiry: SEP17
Test 2 (T2): testosterone HPBCD, 2 mg tablets, IBSA Institut Biochimique S.A., Switzerland. Batch: 007C16-173
expiry: SEP17
Test 3 (T3): T1+T2, i.e. 1 mg tablets + 2 mg tablets for a total dose of 3 mg
Each test investigational product was administered under fasting conditions. A wash out interval of at leas
Sponsors
IBSA Institut Biochimique SA
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent prior to inclusion in the study 2. Menopause: postmenopausal women for at least one year 3. Age: 45-65 year old inclusive 4. Body Mass Index (BMI) from 18.5 to 30 kg/m2 5. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position 6. Testosterone levels: endogenous testosterone levels <3.5 nmol/L (about 1.00 ng/mL) 7. Pap test: normal or not clinically relevant abnormal cervical smears at Papanicolaou test performed within the last 12 months or during the screening phase 8. Mammography: normal or not clinically relevant abnormal mammograms at mammography performed within the last 24 months or during the screening phase 9. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (ECG) 12-leads (supine position): clinically relevant abnormalities 2. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study 5. Diseases: relevant history of cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, immunological, dermatological, endocrine (e.g. hyper-prolactinemia or uncontrolled thyroid and adrenal dysfunction), genitourinary, neurological or psychiatric diseases that could interfere with the aim of the study; malignant neoplasia 6. Medications: intake of other medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study. Intake of any drug affecting the cytochrome P450 for 28 days before the start of the study 7. Hormonal replacement therapy: any hormonal replacement therapy (estrogen-progestin formulations) within 4 weeks, any sex hormone depot injection within 6 months and any sex hormone implants within 5 years before the start of the study 8. Investigative drug trials: participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study 9. Blood donation: blood donations for 3 months before this study 10. Drug, tobacco, alcohol, caffeine: history of drug, alcohol (>1 drink/day, defined according to USDA Dietary Guidelines 2015-2020), caffeine (>5 cups coffee/tea/day) or tobacco (?10 cigarettes per day ) abuse 11. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before the start of this study; vegetarian 12. Pregnancy test: positive urine pregnancy test at screening 13. Drug test: positive abuse drug test at screening 14. Alcohol breath test: positive alcohol breath test at day -1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total testosterone, free testosterone and DHT rate (Cmax) and extent (AUC0-t) of absorption after single dose administration of the test treatments. The concentration of testosterone, DHT, albumin, SHBG was measured in serum at the following time-points: pre-dose (0), 10, 20, 30, 45 min, 1, 1.5, 2, 3, 4, 5, 6 and 8 h post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum pharmacokinetic parameters for total testosterone, free-testosterone and DHT after single dose of the test treatments. The concentration of testosterone, DHT, albumin, SHBG was measured in serum at the following time-points: pre-dose (0), 10, 20, 30, 45 min, 1, 1.5, 2, 3, 4, 5, 6 and 8 h post-dose. 2. Safety of the test treatments, assessed throughout the study | — |
Countries
Switzerland
Outcome results
None listed