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

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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.


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
We found this trial at
1
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Evansville, Indiana 47714
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Evansville, IN
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