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Completed

NCT Number: NCT01943084

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

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.

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Key information

Conditions

Growth Disorder Growth Disorders Healthy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Clinical Trial Call Center

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Area under the serum hGH (human growth hormone) concentration-time curve

    Time frame: From 0 to the time of the last quantifiable concentration over a 24-hour sampling period.

  2. Maximum observed serum hGH concentration

    Time frame: Over a 24-hour sampling period

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

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

  4. Maximum IGF-I effect (Emax)

    Time frame: Over a 96-hour sampling period

Secondary outcomes

  1. The frequency of adverse events (AE)

    Time frame: From screening to follow-up period (up to day 23)

  2. Abnormal haematology laboratory parameters

    Time frame: From screening to follow-up period (up to day 23)

  3. Abnormal biochemistry laboratory parameters

    Time frame: From screening to follow-up period (up to day 23)

  4. The frequency of injection-site reactions

    Time frame: 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)

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

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

  6. Maximum IGFBP-3 effect (Emax)

    Time frame: Over a 96-hour sampling period

  7. Abnormal findings in vital signs

    Time frame: From screening to follow-up period (up to day 23)

  8. Abnormal findings in physical examinations

    Time frame: From screening to follow-up period (up to day

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2013
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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