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

Completed · Phase 1

Conditions studied: Growth Disorder, Healthy

In brief

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.

Key facts

Study ID: NCT01943084
Run by: Novo Nordisk A/S
People needed: 32
Starts: 2013-09-01
Expected to finish: 2013-10-01
Last updated by the study team: 2015-03-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Novo Nordisk Clinical Trial Call Center — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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