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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 curve

Maximum observed serum hGH concentration

Secondary outcome:

Area under the effect (IGF-I) curve

Maximum 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

Page last updated: August 23, 2015

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