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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01943084
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 32.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Disorder; Healthy	Drug: Norditropin® FlexPro® pen; Drug: Genotropin Pen®	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Norditropin®	Drug: 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.
Active Comparator: Genotropin®	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.

Outcome Measures

Primary Outcome Measures

1. Area under the serum hGH (human growth hormone) concentration-time curve [From 0 to the time of the last quantifiable concentration over a 24-hour sampling period.]

2. Maximum observed serum hGH concentration [Over a 24-hour sampling period]

3. Area under the effect (IGF-I) (insulin-like growth factor-I) curve [From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period]

4. Maximum IGF-I effect (Emax) [Over a 96-hour sampling period]

Secondary Outcome Measures

1. The frequency of adverse events (AE) [From screening to follow-up period (up to day 23)]

2. Abnormal haematology laboratory parameters [From screening to follow-up period (up to day 23)]

3. Abnormal biochemistry laboratory parameters [From screening to follow-up period (up to day 23)]

4. The frequency of injection-site reactions [From the time of injection of the trial product to follow-up during the 2 dosing periods (on Days 1 through 5, with visit 7 as follow-up and separately on Days 13 through 17, with visit 12 as follow-up for each period)]

5. Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve [From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period]

6. Maximum IGFBP-3 effect (Emax) [Over a 96-hour sampling period]

7. Abnormal findings in vital signs [From screening to follow-up period (up to day 23)]

8. Abnormal findings in physical examinations [From screening to follow-up period (up to day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Clinical Trial Call Center	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01943084
• Other Study ID Numbers: GH-4108; U1111-1143-0754
• First Posted: Sep 16, 2013
• Last Update Posted: Mar 19, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Growth Disorders

Study Results

No Results Posted as of Mar 19, 2015