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In the present study, the rate and extent of hCG absorption will be compared between the two treatments in healthy women aged 20 to 45 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human hCG | Experimental |
| |
| recombinant hCG | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human hCG 10'000 IU | Drug | A single dose of 10'000 IU of human hCG will be injected in 24 healthy subject volunteers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of absorption (Cmax) | To assess the bioavailability of the test and reference products in terms of rate (baseline-corrected, dose-normalised Cmax) of hCG absorption after single s.c. injection to healthy female subjects. | 192 hours post dose |
| Extent of absorption (AUC0-t), Area under the concentration-time curve | To assess the bioavailability of the test and reference products in terms of extent (baseline-corrected, dose-normalised AUC0-t) of hCG absorption after single s.c. injection to healthy female subjects.Area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method. | 192 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| t1/2: Half-life | To evaluate the baseline-corrected, dose-normalised (when applicable) t1/2 (Half-life) value after single dose administration of test and reference products; | 192 hours post dose |
| Tmax: Time to achieve Cmax |
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Inclusion Criteria:
Informed consent: signed written informed consent before inclusion in the study;
Sex and Age: healthy pre-menopausal women, 20-45 years old inclusive;
Body Mass Index: 18.5-30 kg/m2 inclusive;
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;
Hormonal oral contraceptives: Combined oral contraceptive pill for at least 2 months before the screening visit;
Menstrual cycle: history of a normal menstrual cycle before combined oral contraceptive pill use;
hCG: endogenous hCG levels <1.2 IU/L at screening and Day -1, Period 1;
Pituitary down-regulation: Luteinizing hormone (LH) <5 IU/L; Follicle stimulating hormone (FSH) <4 IU/L at Day -1, Period 1;
Papanicolaou smear (PAP) test: negative or not clinically significant PAP test results within 12 months before the screening visit or at screening;
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;
Additional contraception: study participants with an active sexual life must be using one additional contraceptive method, as follows:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS Research SA | Arzo | Canton Ticino | 6864 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35137345 | Derived | Radicioni M, Leuratti C, Cometti B. Randomized Pharmacokinetic Study of a Highly Purified Human Chorionic Gonadotropin and of a Recombinant Human Chorionic Gonadotropin Following Single Subcutaneous Administration in Healthy Women. Clin Drug Investig. 2022 Mar;42(3):199-206. doi: 10.1007/s40261-022-01118-w. Epub 2022 Feb 9. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Recombinant hCG 6'500 IU | Drug | A single dose of 6'500 IU recombinant hCG will be injected in 24 healthy subject volunteers. |
|
To evaluate the baseline-corrected, dose-normalised (when applicable) Tmax value after single dose administration of test and reference products;
| 192 hours post dose |
| AUC0-∞: Area under the concentration-time curve extrapolated to infinity | 192 hours post dose |
| Frel : Relative bioavailability | calculated as dose-normalised ratio AUC0-t (T)/dose(T) / AUC0-t (R)/dose(R) | 192 hours post dose |
| Treatment emergent adverse events (TEAEs) | percentage of subjects with any TEAE | through study completion up to 46 days. |