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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401244
• Other study ID #: GH-3939
• Secondary ID: U1111-1121-3640
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2011
• Last updated: February 23, 2017
• Start date: July 14, 2011
• Est. completion date: September 27, 2011

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 27, 2011
• Est. primary completion date: September 27, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Dwarfism
• Genetic Disorder
• Growth Disorder
• Growth Disorders
• Healthy
• Idiopathic Short Stature
• Prader-Willi Syndrome

Intervention

Drug:
• somatropin
A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
• somatropin
A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum hGH (human growth hormone) concentration-time curve		from 0 to the time of the last quantifiable concentration over a 24-hour sampling period
Primary	Maximum observed serum hGH concentration		over a 24-hour sampling period
Secondary	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
Secondary	Maximum IGF-I effect (Emax)		over a 96-hour sampling period
Secondary	The frequency of adverse events (AE)		from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Secondary	The frequency of injection site reaction		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)
Secondary	Abnormal hematology laboratory parameters		from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Secondary	Abnormal biochemistry laboratory parameters		from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Secondary	Abnormal findings in physical examinations		from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Secondary	Vital signs		from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

External Links

•   Clinical Trials at Novo Nordisk