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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Prader-Willi Syndrome; Genetic Disorder; Growth Disorder; Idiopathic Short Stature
• Intervention / Treatment: Drug: somatropin; Drug: somatropin

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Novo Nordisk Investigational Site

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norditropin®	Drug: somatropin; A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen; Drug: somatropin; A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12
Active Comparator: Genotropin®	Drug: somatropin; A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen; Drug: somatropin; A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Maximum observed serum hGH concentration	over a 24-hour sampling period

Secondary Outcome Measures

Outcome Measure	Time Frame
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 effect (Emax)	over a 96-hour sampling period
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2011
• Primary Completion (Actual): September 27, 2011
• Study Completion (Actual): September 27, 2011

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Endocrine System Diseases; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Musculoskeletal Diseases; Bone Diseases; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Obesity; Bone Diseases, Developmental; Disease; Prader-Willi Syndrome; Genetic Diseases, Inborn; Growth Disorders; Dwarfism
• Other Study ID Numbers: GH-3939; U1111-1121-3640 (Other Identifier: WHO)