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

Primary Purpose

Growth Disorder, Healthy

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

somatropin

About this trial

This is an interventional treatment trial for Growth Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norditropin®

Nutropin AQ®

Arm Description

Outcomes

Primary Outcome Measures

Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)

Maximum observed serum hGH concentration

Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t)

Maximum IGF-I (insulin-like growth factor-I) effect (Emax)

Secondary Outcome Measures

The frequency of adverse events (AE) and vital signs

The frequency of abnormal hematology

The frequency of abnormal findings in physical examinations

Biochemistry laboratory parameters

The frequency of injection site reaction

Area under the effect (IGFBP-3) curve

Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)

Full Information

NCT ID

NCT01512095

First Posted

January 9, 2012

Last Updated

September 13, 2013

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01512095

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Withdrawn

Study Start Date

August 2013 (undefined)

Primary Completion Date

November 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Growth Disorder, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Norditropin®

Arm Type

Experimental

Arm Title

Nutropin AQ®

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

somatropin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

somatropin

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)

Time Frame

From 0 to the time of the last quantifiable concentration over a 24-hour sampling period

Title

Maximum observed serum hGH concentration

Time Frame

Over a 24-hour sampling period

Title

Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t)

Time Frame

Over a 96-hour sampling period

Title

Maximum IGF-I (insulin-like growth factor-I) effect (Emax)

Time Frame

Over a 96-hour sampling period

Secondary Outcome Measure Information:

Title

The frequency of adverse events (AE) and vital signs

Time Frame

From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation)

Title

The frequency of abnormal hematology

Time Frame

From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)

Title

The frequency of abnormal findings in physical examinations

Time Frame

From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)

Title

Biochemistry laboratory parameters

Time Frame

From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)

Title

The frequency of injection site reaction

Time Frame

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)

Title

Area under the effect (IGFBP-3) curve

Time Frame

From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period

Title

Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)

Time Frame

Over a 96-hour sampling period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Germak

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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