A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

NCT01943084 | Completed Phase 1

• 2 other identifiers: GH-4108U1111-1143-0754
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.

Conditions

Growth Disorder; Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• Area under the effect (IGF-I) (insulin-like growth factor-I) curve

  From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period

• Maximum IGF-I effect (Emax)

  Over a 96-hour sampling period

Secondary Outcomes (8)

• The frequency of adverse events (AE)

  From screening to follow-up period (up to day 23)

• Abnormal haematology laboratory parameters

  From screening to follow-up period (up to day 23)

• Abnormal biochemistry laboratory parameters

  From screening to follow-up period (up to day 23)

• The frequency of injection-site reactions

  From the time of injection of the trial product to follow-up during the 2 dosing periods (on Days 1 through 5, with visit 7 as follow-up and separately on Days 13 through 17, with visit 12 as follow-up for each period)

• Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve

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

Study Arms (2)

Norditropin®

EXPERIMENTAL

Drug: Norditropin® FlexPro® pen

Genotropin®

ACTIVE COMPARATOR

Drug: Genotropin Pen®

Interventions

Norditropin® FlexPro® pen DRUG

Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.

Norditropin®

Genotropin Pen® DRUG

Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.

Genotropin®

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects at trial entry with no previous exposure to recombinant human 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 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 or practice) for the duration of the trial
• Known presence or history of malignancy
• Diabetes mellitus
• Use of systemic corticosteroids
• Use of anabolic steroids
• History of drug or alcohol abuse

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Clinical Trial Call Center

Overland Park, Kansas, 66212, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: September 10, 2013
• First Posted: September 16, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 19, 2015

Record last verified: 2015-01

Locations

US (1)