Clinical trial NCT01401244: Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
Official title: A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Genetic Disorder
Prader-Willi Syndrome
Growth Disorder
Idiopathic Short Stature
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the serum hGH (human growth hormone) concentration-time curve
timeFrame: from 0 to the time of the last quantifiable concentration over a 24-hour sampling period
measure: Maximum observed serum hGH concentration
timeFrame: over a 24-hour sampling period
Secondary outcomes:
measure: Area under the effect (IGF-I) curve
timeFrame: from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
measure: Maximum IGF-I effect (Emax)
timeFrame: over a 96-hour sampling period
measure: The frequency of adverse events (AE)
timeFrame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
measure: The frequency of injection site reaction
timeFrame: 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)
measure: Abnormal hematology laboratory parameters
timeFrame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
measure: Abnormal biochemistry laboratory parameters
timeFrame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
measure: Abnormal findings in physical examinations
timeFrame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
measure: Vital signs
timeFrame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: