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

NCT01512095 | Withdrawn Phase 1

• 3 other identifiers: GH-39582012-003381-40U1111-1122-9661
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Growth Disorder; Healthy

Outcome Measures

Primary Outcomes (4)

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

  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

• 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 (insulin-like growth factor-I) effect (Emax)

  Over a 96-hour sampling period

Secondary Outcomes (7)

• The frequency of adverse events (AE) and vital signs

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

• The frequency of abnormal hematology

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

• The frequency of abnormal findings in physical examinations

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

• Biochemistry laboratory parameters

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

• The frequency of injection site reaction

  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)

Study Arms (2)

Norditropin®

EXPERIMENTAL

Drug: somatropin

Nutropin AQ®

ACTIVE COMPARATOR

Drug: somatropin

Interventions

somatropin DRUG

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

Norditropin®

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Growth Disorders

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

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

• John Germak

  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: January 9, 2012
• First Posted: January 19, 2012
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 16, 2013

Record last verified: 2013-09