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Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

Primary Purpose

Genetic Disorder, Prader-Willi Syndrome, Growth Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

somatropin

About this trial

This is an interventional treatment trial for Genetic Disorder

Eligibility Criteria

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

Inclusion Criteria:

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 (trial physician)

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 (insulin-like growth factor-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 pharmacologic doses of glucocorticoids
Use of anabolic steroids
History of drug or alcohol abuse

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norditropin®

Genotropin®

Arm Description

Outcomes

Primary Outcome Measures

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

Maximum observed serum hGH concentration

Secondary Outcome Measures

Area under the effect (IGF-I) curve

Maximum IGF-I effect (Emax)

The frequency of adverse events (AE)

The frequency of injection site reaction

Abnormal hematology laboratory parameters

Abnormal biochemistry laboratory parameters

Abnormal findings in physical examinations

Vital signs

Full Information

NCT ID

NCT01401244

First Posted

July 20, 2011

Last Updated

February 23, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01401244

Brief Title

Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 14, 2011 (Actual)

Primary Completion Date

September 27, 2011 (Actual)

Study Completion Date

September 27, 2011 (Actual)

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 United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.

6. Conditions and Keywords

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

Genetic Disorder, Prader-Willi Syndrome, Growth Disorder, Idiopathic Short Stature, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Norditropin®

Arm Type

Experimental

Arm Title

Genotropin®

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

somatropin

Intervention Description

A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen

Intervention Type

Drug

Intervention Name(s)

somatropin

Intervention Description

A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

Primary Outcome Measure Information:

Title

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

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

Secondary Outcome Measure Information:

Title

Area under the effect (IGF-I) curve

Time Frame

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

Title

Maximum IGF-I effect (Emax)

Time Frame

over a 96-hour sampling period

Title

The frequency of adverse events (AE)

Time Frame

from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

Title

The frequency of injection site reaction

Time Frame

from the time of injection of the trial product (day 1 and 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively)

Title

Abnormal hematology laboratory parameters

Time Frame

from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

Title

Abnormal biochemistry laboratory parameters

Time Frame

from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

Title

Abnormal findings in physical examinations

Time Frame

from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

Title

Vital signs

Time Frame

from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

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: 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 (trial physician) 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 (insulin-like growth factor-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 pharmacologic doses of glucocorticoids Use of anabolic steroids History of drug or alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47710

Country

United States

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

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