A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy; Growth Disorder
• Interventions: Drug: Genotropin Pen®; Drug: Norditropin® FlexPro® pen

• Registration Number: NCT01943084
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Genotropin®	Genotropin Pen®	-
Norditropin®	Norditropin® FlexPro® pen	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 vital signs	From screening to follow-up period (up to day 23)
Abnormal findings in physical examinations	From screening to follow-up period (up to day

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Overland Park, Kansas, United States