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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Growth Disorder

Treatments

Drug: Norditropin® FlexPro® pen

Drug: Genotropin Pen®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01943084

U1111-1143-0754 (Other Identifier)

GH-4108

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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