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

Novo Nordisk A/S30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Genetic Disorder Prader-Willi Syndrome Growth Disorder Idiopathic Short Stature Healthy

Interventions

somatropinDRUG

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

somatropinDRUG

A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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