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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Growth Disorder
• Intervention / Treatment: Drug: Norditropin® FlexPro® pen; Drug: Genotropin Pen®

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norditropin®	Drug: Norditropin® FlexPro® pen; Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
Active Comparator: Genotropin®	Drug: Genotropin Pen®; Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.

What is the study measuring?

Primary Outcome Measures

Outcome 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
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

Outcome Measure	Time Frame
The frequency of adverse events (AE)	From screening to follow-up period (up to day 23)
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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 16, 2013

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders
• Other Study ID Numbers: GH-4108; U1111-1143-0754 (Other Identifier: WHO)