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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions:A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously
The subjects will attend a screening visit and four treatment sessions. The dosing visits will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay for the infusion group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norditropin SimpleXx sc bolus injection | Other | Single sc bolus injection of 3 mg growth hormone without interval exercise |
|
| Norditropin SimpleXx single sc injection | Other | Single sc bolus injection of 3 mg growth hormone with interval exercise |
|
| Norditropin SimpleXx contin. sc infusion | Other | Continuous sc infusion of 3 mg growth hormone without interval exercise |
|
| Norditropin SimpleXx cont. sc infusion | Other | Continuous sc infusion of 3 mg growth hormone with interval exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norditropin SimpleXx (growth hormone) | Drug | 3mg/subject/day over two consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profiles of growth hormone | Pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as a bolus in the adult patients with growth hormone deficiency during interval exercise or in supine rest. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profiles of growth hormone | To compare pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as an infusion in the adult patients with growth hormone deficiency during interval exercise or in supine rest. | 60 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torben Laursen, professor | Institute of Pharmacology, Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Department M, Aarhus University Hospital | Aarhus C | Central Jutland | 8000 | Denmark | ||
| Aarhus University Hospital |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Aarhus C |
| 8000 |
| Denmark |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |