Status:
COMPLETED
Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Genetic Disorder
Prader-Willi Syndrome
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01401244
Start Date
July 14 2011
End Date
September 27 2011
Last Update
February 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47710