DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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Status: Withdrawn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 signs

The 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017