Relative Bioavailability
Conditions
Brief summary
1. Compares and evaluates the relative bioavailability of single-dose subcutaneous administration of each of the Eutropin formulations to healthy male volunteers. 2. Ensure safety and tolerability of single, subcutaneous administration of Eutropin formulations to healthy male volunteers.
Interventions
DRUGEutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU
Investigate the Relative Bioavailability among Different Eutropin Formulations
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
6x3 Crossover Study
Eligibility
Sex/Gender
MALE
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. A healthy male who is at least 19 years old but under 40 years of age at screening visit 2. Those who weigh more than 50 kg at screening visit and whose body mass index (BMI) is greater than 19 kg / m2 but less than 28 kg / m2 3. The result of the vital signs in the screening period. 4. A person who is judged to be clinically insignificant in terms of physical or mental condition when the examinee medically judges the screening period physical examination 5. Those who are not clinically significant when the examiner has medically judged the results of examination other than the items described in 17) and 18) of the exclusion criterion in the diagnosis laboratory test results in the screening period 6. A person who consents to use a combination of effective contraceptive methods or medically appropriate contraceptive methods from the first administration of the clinical trial drug to the fourth administration (28 days) after the last administration of the drug for clinical trial and not to provide sperm 7. Those who voluntarily decide to participate in clinical trials and observe the test subjects' precautions and agree in writing
Exclusion criteria
1. Those who with a history or history of diabetes 2. Those who with a history or history of malignancy 3. Those who with a history or history of musculoskeletal disorders (including epiphyseal closure, scoliosis, etc.) 4. Those who with history or history of endocrine system (including hypothyroidism, panhypopituitarism, etc.) 5. 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. 6.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast of somatropin | Total three period at weekly intervals (Week 1, Week2, Week3) | Pharmacokinetic assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of somatropin | Total three period at weekly intervals (Week 1, Week2, Week3) | Pharmacokinetic assessment |
| Area under the plasma concentration versus time curve (AUCinf) of somatropin | Total three period at weekly intervals (Week 1, Week2, Week3) | Pharmacokinetic assessment |
| Time at which the Cmax is observed (Tmax) of somatropin | Total three period at weekly intervals (Week 1, Week2, Week3) | Pharmacokinetic assessment |
| Elimination half-life time (t1/2β) of somatropin | Total three period at weekly intervals (Week 1, Week2, Week3) | Pharmacokinetic assessment |
| IGF-BP3 | Total three period at weekly intervals (Week 1, Week2, Week3) | Pharmacodynamic assessment |
| IGF-1 | Total three period at weekly intervals (Week 1, Week2, Week3) | Pharmacodynamic assessment |
| Physical examination | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 | Weight, Height |
| Vital Signs | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 | Left-sided blood pressure (systolic / diastolic), pulse rate, tympanic temperature |
| Electrocardiogram | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 | Ventricular rate, PR interval, QRS, QT/QTc |
| Laboratory test | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 | General blood test, general chemical test, clinical chemistry urinalysis, pancreas test |
| Injection site reaction and Pain scale evaluation | Week 1, Week 2, Week 3 | Ask the NRS about the degree of pain and evaluate it as 0-10 |
| Monitoring of adverse reactions | Week -4(Screening), Week 1, Week 2, Week 3, Week 5 | Clinical significance is assessed by reviewing the general findings of individual subjects individually, and when there is a specific or tendency, analysis is conducted |
Countries
South Korea
Outcome results
None listed