Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genetic Disorder; Prader-Willi Syndrome; Growth Disorder; Idiopathic Short Stature; Healthy
Intervention: somatropin (Drug); somatropin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): John Germak, Study Director, Affiliation: Novo Nordisk A/S
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.
Clinical Details
Official title: A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the serum hGH (human growth hormone) concentration-time curveMaximum observed serum hGH concentration
Secondary outcome: Area under the effect (IGF-I) curveMaximum IGF-I effect (Emax) The frequency of adverse events (AE) The frequency of injection site reaction Abnormal hematology laboratory parameters Abnormal biochemistry laboratory parameters Abnormal findings in physical examinations Vital signs
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Novo Nordisk Clinical Trial Call Center, Evansville, Indiana 47710, United States
Additional Information
Clinical Trials at Novo Nordisk
Starting date: July 2011
Last updated: April 23, 2013
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