Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers

Healthy Clinical Trial

Official title:

A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01512095
• Other study ID #: GH-3958
• Secondary ID: 2012-003381-40U1
• Status: Withdrawn
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: September 13, 2013
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• 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 Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• No previous exposure to recombinant human GH (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 recombinant human 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) for the duration of the trial

• Known presence or history of malignancy

• Diabetes mellitus

• Use of pharmacologic doses of glucocorticoids

• 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:
• somatropin
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
• somatropin
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)		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) curve from time 0 to the time of the last concentration (AUEC0-t)		Over a 96-hour sampling period	No
Primary	Maximum IGF-I (insulin-like growth factor-I) effect (Emax)		Over a 96-hour sampling period	No
Secondary	The frequency of adverse events (AE) and vital signs		From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation)	No
Secondary	The frequency of abnormal hematology		From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)	No
Secondary	The frequency of abnormal findings in physical examinations		From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)	No
Secondary	Biochemistry laboratory parameters		From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)	No
Secondary	The frequency of injection site reaction		From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17)	No
Secondary	Area under the effect (IGFBP-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 (insulin-like growth factor binding protein 3) effect (Emax)		Over a 96-hour sampling period	No

External Links

•   Clinical Trials at Novo Nordisk