Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) 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: Growth Disorder; Healthy
Intervention: somatropin (Drug); somatropin (Drug)
Phase: Phase 1
Status: Withdrawn
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 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 drug products with identical active ingredient) of Norditropin® versus
Nutropin AQ® in healthy adult volunteers.
Clinical Details
Official title: A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® 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 curve (AUC0-t)Maximum observed serum hGH concentration Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t) Maximum IGF-I (insulin-like growth factor-I) effect (Emax)
Secondary outcome: The frequency of adverse events (AE) and vital signsThe frequency of abnormal hematology The frequency of abnormal findings in physical examinations Biochemistry laboratory parameters The frequency of injection site reaction Area under the effect (IGFBP-3) curve Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Additional Information
Clinical Trials at Novo Nordisk
Starting date: August 2013
Last updated: September 13, 2013
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