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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943084
• Other study ID #: GH-4108
• Secondary ID: U1111-1143-0754
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2013
• Last updated: March 18, 2015
• Start date: September 2013
• Est. completion date: October 2013

Study information

• Verified date: January 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth Disorder
• Growth Disorders
• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Maximum observed serum hGH concentration		Over a 24-hour sampling period	No
Primary	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	No
Primary	Maximum IGF-I effect (Emax)		Over a 96-hour sampling period	No
Secondary	The frequency of adverse events (AE)		From screening to follow-up period (up to day 23)	No
Secondary	Abnormal haematology laboratory parameters		From screening to follow-up period (up to day 23)	No
Secondary	Abnormal biochemistry laboratory parameters		From screening to follow-up period (up to day 23)	No
Secondary	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)	No
Secondary	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	No
Secondary	Maximum IGFBP-3 effect (Emax)		Over a 96-hour sampling period	No
Secondary	Abnormal findings in vital signs		From screening to follow-up period (up to day 23)	No
Secondary	Abnormal findings in physical examinations		From screening to follow-up period (up to day	No

External Links

•   Clinical Trials at Novo Nordisk