Bioequivalence of Two Somatropin Products (Norditropin® V... | NCT01401244

Studies
Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

NCT01401244

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 24, 2017Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Genetic Disorder
Prader-Willi Syndrome
Growth Disorder
Idiopathic Short Stature
Healthy

Interventions

somatropin
somatropin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1121-3640	Other Identifier	WHO

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2011Actual

Primary Completion Date

Sep 27, 2011Actual

Completion Date

Sep 27, 2011Actual

First Submitted Date

Jul 20, 2011

First Submission Date that Met QC Criteria

Jul 22, 2011

First Posted Date

Jul 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2017

Last Update Posted Date

Feb 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Norditropin®	Experimental		Drug: somatropin
Genotropin®	Active Comparator		Drug: somatropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug	A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen	Norditropin®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Maximum observed serum hGH concentration		over a 24-hour sampling period

Secondary Outcomes

Measure	Description	Time Frame
Area under the effect (IGF-I) curve		from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
Maximum IGF-I effect (Emax)		over a 96-hour sampling period

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Evansville	Indiana	47710	United States

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D030342	Genetic Diseases, Inborn
D011218	Prader-Willi Syndrome
D006130	Growth Disorders

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019382	Human Growth Hormone

Ancestor Terms

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided