Overview

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

Status:
Completed
Trial end date:
2011-09-27
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
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