A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

Condition(s) targeted: Growth Disorder; Healthy

Intervention: Norditropin® FlexPro® pen (Drug); Genotropin Pen® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.

Official title: A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

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

Area under the effect (IGF-I) (insulin-like growth factor-I) curve

Maximum IGF-I effect (Emax)

Secondary outcome:

The frequency of adverse events (AE)

Abnormal haematology laboratory parameters

Abnormal biochemistry laboratory parameters

The frequency of injection-site reactions

Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve

Maximum IGFBP-3 effect (Emax)

Abnormal findings in vital signs

Abnormal findings in physical examinations

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy subjects at trial entry with no previous exposure to recombinant human 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 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 or practice) for the duration of the trial

- Known presence or history of malignancy

- Diabetes mellitus

- Use of systemic corticosteroids

- Use of anabolic steroids

- History of drug or alcohol abuse

Novo Nordisk Clinical Trial Call Center, Overland Park, Kansas 66212, United States

Clinical Trials at Novo Nordisk

Starting date: September 2013
Last updated: March 18, 2015