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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1143-0754 | Other Identifier | WHO |
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This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norditropin® | Experimental |
| |
| Genotropin® | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norditropin® FlexPro® pen | Drug | Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum hGH (human growth hormone) concentration-time curve | From 0 to the time of the last quantifiable concentration over a 24-hour sampling period. | |
| Maximum observed serum hGH concentration | Over a 24-hour sampling period | |
| Area under the effect (IGF-I) (insulin-like growth factor-I) curve | From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period | |
| Maximum IGF-I effect (Emax) | Over a 96-hour sampling period |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of adverse events (AE) | From screening to follow-up period (up to day 23) | |
| Abnormal haematology laboratory parameters | From screening to follow-up period (up to day 23) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Genotropin Pen® | Drug | Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period. |
|
| Abnormal biochemistry laboratory parameters |
| From screening to follow-up period (up to day 23) |
| The frequency of injection-site reactions | From the time of injection of the trial product to follow-up during the 2 dosing periods (on Days 1 through 5, with visit 7 as follow-up and separately on Days 13 through 17, with visit 12 as follow-up for each period) |
| Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve | From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period |
| Maximum IGFBP-3 effect (Emax) | Over a 96-hour sampling period |
| Abnormal findings in vital signs | From screening to follow-up period (up to day 23) |
| Abnormal findings in physical examinations | From screening to follow-up period (up to day |