Growth Disorder, Healthy
Conditions
Brief summary
This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.
Interventions
Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
DRUGGenotropin Pen®
Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects at trial entry with no previous exposure to recombinant human growth hormone or IGF-I (insulin-like growth factor-I) * Body mass index (BMI) 18.0-27.0 kg/m\^2 (both inclusive) * Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the investigator
Exclusion criteria
* The receipt of any investigational medicinal product within 1 month prior to this trial * Current or previous treatment with growth hormone or IGF-I * Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) for the duration of the trial * Known presence or history of malignancy * Diabetes mellitus * Use of systemic corticosteroids * Use of anabolic steroids * History of drug or alcohol abuse
Design outcomes
Primary
| Measure | 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 24-hour sampling period. |
| Maximum observed serum hGH concentration | Over a 24-hour sampling period |
| Area under the effect (IGF-I) (insulin-like growth factor-I) curve | From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period |
| Maximum IGF-I effect (Emax) | Over a 96-hour sampling period |
Secondary
| Measure | Time frame |
|---|---|
| Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve | From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period |
| Maximum IGFBP-3 effect (Emax) | Over a 96-hour sampling period |
| The frequency of adverse events (AE) | From screening to follow-up period (up to day 23) |
| Abnormal findings in physical examinations | From screening to follow-up period (up to day |
| Abnormal findings in vital signs | From screening to follow-up period (up to day 23) |
| Abnormal haematology laboratory parameters | From screening to follow-up period (up to day 23) |
| Abnormal biochemistry laboratory parameters | From screening to follow-up period (up to day 23) |
| The frequency of injection-site reactions | From the time of injection of the trial product to follow-up during the 2 dosing periods (on Days 1 through 5, with visit 7 as follow-up and separately on Days 13 through 17, with visit 12 as follow-up for each period) |
Countries
United States
Outcome results
None listed