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The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-032 30mg | Experimental | A single dose 30mg administered orally |
|
| HL-032 60mg | Experimental | A single dose 60mg administered orally |
|
| HL-032 120mg | Experimental | A single dose 120mg administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin |
|
| 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 32-hour sampling period | |
| Maximum observed serum hGH concentration | Over a 32-hour sampling period |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the effect(IGF-1, IGFBP-3, NEFA)curve | From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period | |
| Maximum IGF-1, IGFBP-3, NEFA effect | Over a 32-hour sampling period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, Medicine | Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute | Seoul | 110-744 | South Korea |
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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 |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Placebo | Drug | Tablets, oral administrations |
|
| 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |