- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943084
A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects
March 18, 2015 updated by: Novo Nordisk A/S
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Novo Nordisk Clinical Trial Call Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Norditropin®
|
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®
|
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
Time Frame: From 0 to the time of the last quantifiable concentration over a 24-hour sampling period.
|
From 0 to the time of the last quantifiable concentration over a 24-hour sampling period.
|
Maximum observed serum hGH concentration
Time Frame: Over a 24-hour sampling period
|
Over a 24-hour sampling period
|
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
|
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)
Time Frame: Over a 96-hour sampling period
|
Over a 96-hour sampling period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The frequency of adverse events (AE)
Time Frame: From screening to follow-up period (up to day 23)
|
From screening to follow-up period (up to day 23)
|
Abnormal haematology laboratory parameters
Time Frame: From screening to follow-up period (up to day 23)
|
From screening to follow-up period (up to day 23)
|
Abnormal biochemistry laboratory parameters
Time Frame: From screening to follow-up period (up to day 23)
|
From screening to follow-up period (up to day 23)
|
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)
|
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
Time Frame: From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
|
From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
|
Maximum IGFBP-3 effect (Emax)
Time Frame: Over a 96-hour sampling period
|
Over a 96-hour sampling period
|
Abnormal findings in vital signs
Time Frame: From screening to follow-up period (up to day 23)
|
From screening to follow-up period (up to day 23)
|
Abnormal findings in physical examinations
Time Frame: From screening to follow-up period (up to day
|
From screening to follow-up period (up to day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- GH-4108
- U1111-1143-0754 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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