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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy; Growth Disorder
• Intervention / Treatment: Drug: somatropin

• Study Type: Interventional
• Phase: Phase 1

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:

• 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 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: somatropin; A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
Active Comparator: Nutropin AQ®	Drug: somatropin; A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed serum hGH concentration	Over a 24-hour sampling period
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
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
Maximum IGF-I (insulin-like growth factor-I) effect (Emax)	Over a 96-hour sampling period

Secondary Outcome Measures

Outcome Measure	Time Frame
The frequency of adverse events (AE) and vital signs	From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation)
The frequency of abnormal hematology	From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
The frequency of abnormal findings in physical examinations	From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
Biochemistry laboratory parameters	From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
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)
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
Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)	Over a 96-hour sampling period

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: John Germak, Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): November 1, 2013

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 13, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders
• Other Study ID Numbers: GH-3958; 2012-003381-40 (EudraCT Number); U1111-1122-9661 (Other Identifier: WHO)