Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers

Novo Nordisk

Status and phase

Withdrawn

Phase 1

Conditions

Healthy

Growth Disorder

Treatments

Drug: somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01512095

GH-3958

U1111-1122-9661 (Other Identifier)

2012-003381-40 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

No previous exposure to recombinant human GH (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 recombinant human 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) 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