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

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Healthy
Growth Disorder

Treatments

Drug: Norditropin® FlexPro® pen
Drug: Genotropin Pen®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01943084
U1111-1143-0754 (Other Identifier)
GH-4108

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Norditropin®
Experimental group
Treatment:
Drug: Norditropin® FlexPro® pen
Genotropin®
Active Comparator group
Treatment:
Drug: Genotropin Pen®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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