Status:
WITHDRAWN
Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Disorder
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical dr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01512095
Start Date
August 1 2013
End Date
November 1 2013
Last Update
September 16 2013
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