A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 10/19/2013 |
| Start Date: | September 2013 |
| End Date: | October 2013 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
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.
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
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