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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eutropin 4IU | Experimental |
| |
| Eutropin AQ 12IU | Experimental |
| |
| Eutropin Pen 36IU | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU | Drug | Investigate the Relative Bioavailability among Different Eutropin Formulations |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of somatropin | Pharmacokinetic assessment | Total three period at weekly intervals (Week 1, Week2, Week3) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of somatropin | Pharmacokinetic assessment | Total three period at weekly intervals (Week 1, Week2, Week3) |
| Area under the plasma concentration versus time curve (AUCinf) of somatropin |
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Inclusion Criteria:
Exclusion Criteria:
Those who with a history or history of diabetes
Those who with a history or history of malignancy
Those who with a history or history of musculoskeletal disorders (including epiphyseal closure, scoliosis, etc.)
Those who with history or history of endocrine system (including hypothyroidism, panhypopituitarism, etc.)
Those who have a history of skin disease, including psoriasis and contact dermatitis, or who can not exclude the possibility of skin disease under the judgment of the examiner on physical examination conducted at the screening visit.
Exclusion Criteria In addition to items 1) to 5), there are other clinically significant history or history of liver, kidney, digestive system, respiratory system, neuropsychiatry, blood /
Persons with a history of somatropin and octreotide acetate or hypersensitivity reactions to cresol, glycerol or other drugs (non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Those who have participated in other clinical trials or bioequivalence tests within 90 days of the screening visit date
Within 60 days before screening visit Those who have received blood (blood, whole blood, etc.) or blood transfusions
Those who ingest herbal medicines or health functional foods within 14 days before the screening visit or those who are expected to affect the clinical trial within 7 days
Within 14 days prior to screening visit, special medicines that may affect the clinical trial, or those who use general medicines within 7 days
Screening Within 30 days prior to the visiting date Alcohol Abuse (alcohol-containing beverage> 21 units / week)
Over 30 days before screening visit Overcame smoker (cigarette> 10 cigarettes / day)
Within 7 days of screening visit Caffeine-containing foods Excessive intake (caffeinated foods> 3 times / week)
Screening Within 7 days prior to the visit Date of intake of food containing xanthine
As a result of urine nicotine test or urine drug screening test during the screening period
Screening period serum test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test) Result positive
Diagnosis of Screening Period In the case of a laboratory test, one or more of the following findings
A 12-electrode electrocardiogram in the screening period revealed a QTc> 450 ms or clinically significant abnormalities
Those who are judged to be inadequate to perform the clinical trial when the examiners judge them for other reasons
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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6x3 Crossover Study
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Pharmacokinetic assessment
| Total three period at weekly intervals (Week 1, Week2, Week3) |
| Time at which the Cmax is observed (Tmax) of somatropin | Pharmacokinetic assessment | Total three period at weekly intervals (Week 1, Week2, Week3) |
| Elimination half-life time (t1/2β) of somatropin | Pharmacokinetic assessment | Total three period at weekly intervals (Week 1, Week2, Week3) |
| IGF-1 | Pharmacodynamic assessment | Total three period at weekly intervals (Week 1, Week2, Week3) |
| IGF-BP3 | Pharmacodynamic assessment | Total three period at weekly intervals (Week 1, Week2, Week3) |
| Monitoring of adverse reactions | Clinical significance is assessed by reviewing the general findings of individual subjects individually, and when there is a specific or tendency, analysis is conducted | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 |
| Physical examination | Weight, Height | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 |
| Vital Signs | Left-sided blood pressure (systolic / diastolic), pulse rate, tympanic temperature | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 |
| Electrocardiogram | Ventricular rate, PR interval, QRS, QT/QTc | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 |
| Laboratory test | General blood test, general chemical test, clinical chemistry urinalysis, pancreas test | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 |
| Injection site reaction and Pain scale evaluation | Ask the NRS about the degree of pain and evaluate it as 0-10 | Week 1, Week 2, Week 3 |