Relative Bioavailability Among Different Eutropin Formulations

NCT03154840 | Unknown Phase 1

• 1 other identifier: LG-HGCL009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Compares and evaluates the relative bioavailability of single-dose subcutaneous administration of each of the Eutropin formulations to healthy male volunteers.
2. 2.Ensure safety and tolerability of single, subcutaneous administration of Eutropin formulations to healthy male volunteers.

Conditions

Relative Bioavailability

Outcome Measures

Primary Outcomes (1)

• AUClast of somatropin

  Pharmacokinetic assessment

  Total three period at weekly intervals (Week 1, Week2, Week3)

Secondary Outcomes (12)

• Peak Plasma Concentration (Cmax) of somatropin

  Total three period at weekly intervals (Week 1, Week2, Week3)

• Area under the plasma concentration versus time curve (AUCinf) of somatropin

  Total three period at weekly intervals (Week 1, Week2, Week3)

• Time at which the Cmax is observed (Tmax) of somatropin

  Total three period at weekly intervals (Week 1, Week2, Week3)

• Elimination half-life time (t1/2β) of somatropin

  Total three period at weekly intervals (Week 1, Week2, Week3)

• IGF-1

  Total three period at weekly intervals (Week 1, Week2, Week3)

Study Arms (3)

Eutropin 4IU

EXPERIMENTAL

Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU

Eutropin AQ 12IU

EXPERIMENTAL

Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU

Eutropin Pen 36IU

EXPERIMENTAL

Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU

Interventions

Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU DRUG

Investigate the Relative Bioavailability among Different Eutropin Formulations

Eutropin 4IU; Eutropin AQ 12IU; Eutropin Pen 36IU

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy male who is at least 19 years old but under 40 years of age at screening visit
• 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
• The result of the vital signs in the screening period.
• 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
• 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
• Those who voluntarily decide to participate in clinical trials and observe the test subjects' precautions and agree in writing

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Officials

• Kyun-Seop Bae

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 6x3 Crossover Study

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 16, 2017
• Study Start: May 31, 2017
• Primary Completion: July 10, 2017
• Study Completion: November 30, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

KR (1)