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Completed

NCT Number: NCT01401244

Bioequivalence of Two Somatropin Products (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.

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Key information

Conditions

Genetic Disorder Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Growth Disorder Growth Disorders Healthy Idiopathic Short Stature Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Prader-Willi Syndrome

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Evansville, Indiana, 47710, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Somatropin

Drug

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

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

Secondary outcomes

  1. Area under the effect (IGF-I) curve

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

  2. Maximum IGF-I effect (Emax)

    Time frame: over a 96-hour sampling period

  3. The frequency of adverse events (AE)

    Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

  4. The frequency of injection site reaction

    Time frame: 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)

  5. Abnormal hematology laboratory parameters

    Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

  6. Abnormal biochemistry laboratory parameters

    Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

  7. Abnormal findings in physical examinations

    Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

  8. Vital signs

    Time frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 25, 2011
Registry last updated
Feb 24, 2017

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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