Genetic Disorder, Growth Disorder, Healthy, Idiopathic Short Stature, Prader-Willi Syndrome
Conditions
Brief summary
This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
Interventions
DRUGsomatropin
A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
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
No
Inclusion criteria
* 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 (trial physician)
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 (insulin-like growth factor-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 pharmacologic doses of glucocorticoids * 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 |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of adverse events (AE) | from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) |
| The frequency of injection site reaction | from the time of injection of the trial product (day 1 and 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively) |
| Abnormal hematology laboratory parameters | from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) |
| Area under the effect (IGF-I) curve | from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period |
| Abnormal findings in physical examinations | from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) |
| Vital signs | from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) |
| Abnormal biochemistry laboratory parameters | from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) |
| Maximum IGF-I effect (Emax) | over a 96-hour sampling period |
Countries
United States
Outcome results
None listed