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

Overview

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.

Full Title of Study: “A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 27, 2011

Interventions

  • Drug: somatropin
    • A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
  • Drug: somatropin
    • A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

Arms, Groups and Cohorts

  • Experimental: Norditropin®
  • Active Comparator: Genotropin®

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Maximum observed serum hGH concentration
    • Time Frame: over a 24-hour sampling period

Secondary Measures

  • 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
  • Maximum IGF-I effect (Emax)
    • Time Frame: over a 96-hour sampling period
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

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