Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies, Women's Studies, Endocrine, Endocrine |
Therapuetic Areas: | Endocrinology, Other, Reproductive |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 2/25/2017 |
Start Date: | July 14, 2011 |
End Date: | September 27, 2011 |
A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
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.
examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
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
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