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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-14

Study Completion Date

2011-09-27

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Norditropin®

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen

Genotropin®

Group Type ACTIVE_COMPARATOR

somatropin

Intervention Type DRUG

A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

Interventions

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somatropin

A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen

Intervention Type DRUG

somatropin

A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No