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

Primary Purpose

Growth Disorder, Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Norditropin® FlexPro® pen
Genotropin Pen®
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Novo Nordisk Clinical Trial Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norditropin®

Genotropin®

Arm Description

Outcomes

Primary Outcome Measures

Area under the serum hGH (human growth hormone) concentration-time curve
Maximum observed serum hGH concentration
Area under the effect (IGF-I) (insulin-like growth factor-I) curve
Maximum IGF-I effect (Emax)

Secondary Outcome Measures

The frequency of adverse events (AE)
Abnormal haematology laboratory parameters
Abnormal biochemistry laboratory parameters
The frequency of injection-site reactions
Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve
Maximum IGFBP-3 effect (Emax)
Abnormal findings in vital signs
Abnormal findings in physical examinations

Full Information

First Posted
September 10, 2013
Last Updated
March 18, 2015
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01943084
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorder, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norditropin®
Arm Type
Experimental
Arm Title
Genotropin®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Norditropin® FlexPro® pen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Genotropin Pen®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area under the serum hGH (human growth hormone) concentration-time curve
Time Frame
From 0 to the time of the last quantifiable concentration over a 24-hour sampling period.
Title
Maximum observed serum hGH concentration
Time Frame
Over a 24-hour sampling period
Title
Area under the effect (IGF-I) (insulin-like growth factor-I) curve
Time Frame
From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period
Title
Maximum IGF-I effect (Emax)
Time Frame
Over a 96-hour sampling period
Secondary Outcome Measure Information:
Title
The frequency of adverse events (AE)
Time Frame
From screening to follow-up period (up to day 23)
Title
Abnormal haematology laboratory parameters
Time Frame
From screening to follow-up period (up to day 23)
Title
Abnormal biochemistry laboratory parameters
Time Frame
From screening to follow-up period (up to day 23)
Title
The frequency of injection-site reactions
Time Frame
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)
Title
Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve
Time Frame
From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
Title
Maximum IGFBP-3 effect (Emax)
Time Frame
Over a 96-hour sampling period
Title
Abnormal findings in vital signs
Time Frame
From screening to follow-up period (up to day 23)
Title
Abnormal findings in physical examinations
Time Frame
From screening to follow-up period (up to day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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