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

NCT01401244 | Completed Phase 1

• 2 other identifiers: GH-3939U1111-1121-3640
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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)

Study Arms (2)

Norditropin®

EXPERIMENTAL

Drug: somatropin

Genotropin®

ACTIVE COMPARATOR

Drug: somatropin

Interventions

somatropin DRUG

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

Norditropin®

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Evansville, Indiana, 47710, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Genetic Diseases, Inborn; Prader-Willi Syndrome; Growth Disorders

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 25, 2011
• Study Start: July 14, 2011
• Primary Completion: September 27, 2011
• Study Completion: September 27, 2011
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

US (1)