Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | October 2012 |
| End Date: | November 2012 |
| Contact: | Novo Nordisk Clinical Trial Call Center |
| Phone: | 866-867-7178 |
A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers
This trial is conducted in 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.
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
We found this trial at
2
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