Clinical trial NCT01943084: A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects
Official title: A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Disorder
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-09-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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
measure: Area under the effect (IGF-I) (insulin-like growth factor-I) curve
timeFrame: From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period
measure: Maximum IGF-I effect (Emax)
timeFrame: Over a 96-hour sampling period
Secondary outcomes:
measure: The frequency of adverse events (AE)
timeFrame: From screening to follow-up period (up to day 23)
measure: Abnormal haematology laboratory parameters
timeFrame: From screening to follow-up period (up to day 23)
measure: Abnormal biochemistry laboratory parameters
timeFrame: From screening to follow-up period (up to day 23)
measure: The frequency of injection-site reactions
timeFrame: 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)
measure: Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 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 effect (Emax)
timeFrame: Over a 96-hour sampling period
measure: Abnormal findings in vital signs
timeFrame: From screening to follow-up period (up to day 23)
measure: Abnormal findings in physical examinations
timeFrame: From screening to follow-up period (up to day
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Kansas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: