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

NCT ID: NCT01943084

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-10-31

Brief Summary

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.

Conditions

Growth Disorder; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Norditropin®

Group Type: EXPERIMENTAL

Norditropin® FlexPro® pen

Intervention Type: DRUG

Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.

Genotropin®

Group Type: ACTIVE_COMPARATOR

Genotropin Pen®

Intervention Type: DRUG

Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.

Interventions

Norditropin® FlexPro® pen

Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.

Intervention Type: DRUG

Genotropin Pen®

Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Clinical Trial Call Center

Overland Park, Kansas, United States

Countries

United States

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1143-0754

Identifier Type: OTHER

Identifier Source: secondary_id

GH-4108

Identifier Type: -

Identifier Source: org_study_id