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