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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003381-40 | EudraCT Number | ||
| U1111-1122-9661 | Other Identifier | WHO |
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This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norditropin® | Experimental |
| |
| Nutropin AQ® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t) | 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) curve from time 0 to the time of the last concentration (AUEC0-t) | Over a 96-hour sampling period | |
| Maximum IGF-I (insulin-like growth factor-I) effect (Emax) | Over a 96-hour sampling period |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of adverse events (AE) and vital signs | From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation) | |
| The frequency of abnormal hematology | From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Germak | Novo Nordisk A/S | Study Director |
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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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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| somatropin | Drug | A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period |
|
| The frequency of abnormal findings in physical examinations | From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) |
| Biochemistry laboratory parameters | From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) |
| The frequency of injection site reaction | From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17) |
| Area under the effect (IGFBP-3) curve | From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period |
| Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax) | Over a 96-hour sampling period |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |