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

Phase 1

Withdrawn

• Conditions: Growth Disorder; Healthy
• Interventions: Drug: somatropin

• Registration Number: NCT01512095
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-19
• Study Start: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-16
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nutropin AQ®	somatropin	-
Norditropin®	somatropin	-

Primary Outcome Measures

Name	Time	Method
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
Maximum observed serum hGH 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

Name	Time	Method
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