Clinical trial NCT01512095: Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers
Official title: A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Growth Disorder
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 0
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 Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* No previous exposure to recombinant human GH (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 recombinant human 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) 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 (AUC0-t)
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
measure: Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t)
timeFrame: Over a 96-hour sampling period
measure: Maximum IGF-I (insulin-like growth factor-I) effect (Emax)
timeFrame: Over a 96-hour sampling period
Secondary outcomes:
measure: The frequency of adverse events (AE) and vital signs
timeFrame: From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation)
measure: The frequency of abnormal hematology
timeFrame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
measure: The frequency of abnormal findings in physical examinations
timeFrame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
measure: Biochemistry laboratory parameters
timeFrame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
measure: The frequency of injection site reaction
timeFrame: From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17)
measure: Area under the effect (IGFBP-3) curve
timeFrame: From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
measure: Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)
timeFrame: Over a 96-hour sampling period
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: John Germak
role: STUDY_DIRECTOR
References: