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

Phase 1

Completed

• Conditions: Growth Disorder; Healthy; Prader-Willi Syndrome; Idiopathic Short Stature; Genetic Disorder
• Interventions: Drug: somatropin

• Registration Number: NCT01401244
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-14
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2011-09-27
• Study Completion: 2011-09-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Norditropin®	somatropin	-
Genotropin®	somatropin	-

Primary Outcome Measures

Name	Time	Method
Maximum observed serum hGH concentration	over a 24-hour sampling period
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

Secondary Outcome Measures

Name	Time	Method
The frequency of injection site reaction	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)
The frequency of adverse events (AE)	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	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	from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Maximum IGF-I effect (Emax)	over a 96-hour sampling period
Area under the effect (IGF-I) curve	from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
Vital signs	from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)
Abnormal hematology laboratory parameters	from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Evansville, Indiana, United States