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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005756-24 | EudraCT Number |
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Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects. Only female subjects will be included in the study to reach the objectives of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XM17 | Experimental | XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL. |
|
| Gonal-f® | Experimental | Gonal-f® will be provided in pens with integrated vials of 0.5 mL |
|
| Zoladex® | Active Comparator | Zoladex® 3.6 mg will be administered by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XM17 | Drug | 300 IU corresponds to an injection volume of 0.5 mL. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of single dose pharmacokinetics (Cmax) | XM17 and Gonal-f® tested statistically for bioequivalence. | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Comparison of single dose pharmacokinetics (AUC0-t) | XM17 and Gonal-f® tested statistically for bioequivalence. | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics AUC0-∞ | Area under the XM17 / Gonal-f® concentration time curve from time 0 extrapolated to infinity | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Pharmacokinetics AUC0-168h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26621118 | Derived | Lammerich A, Mueller A, Bias P. Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f(R) in healthy women after follicle-stimulating hormone downregulation. Reprod Biol Endocrinol. 2015 Dec 1;13:130. doi: 10.1186/s12958-015-0124-y. |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Gonal-f® |
| Drug |
300 IU corresponds to an injection volume of 0.5 mL. |
|
|
| Zoladex® | Drug | 3.6 mg |
|
|
Area under the XM17 / Gonal-f® concentration time curve from time 0 to 168 h |
| Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Pharmacokinetics Cmax,obs | Maximum XM17 / Gonal-f® concentration determined during the interval of sample taking | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Pharmacokinetics Tmax | Time to maximum XM17 / Gonal-f® concentration | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Pharmacokinetics λZ | Apparent terminal elimination rate constant. | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Pharmacokinetics t1/2 | Apparent terminal elimination half life. | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Pharmacokinetics CL/F | Serum clearance after dosing | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Pharmacokinetics Vz/F | Volume of Distribution during the terminal phase after extravascular administration | Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose |
| Percentage of participants with adverse events | Signing of informed consent to final data collection (27 days) |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |