Who is sponsoring NCT01943084?

NCT01943084 is sponsored by Novo Nordisk A/S.

What condition does NCT01943084 study?

NCT01943084 studies Growth Disorder, Healthy.

What drugs are being tested in NCT01943084?

Interventions: Norditropin® FlexPro® pen, Genotropin Pen®.

What is the status of NCT01943084?

NCT01943084 is currently COMPLETED.

Last reviewed 2015-03-18 · How we verify

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

NCT01943084 Phase 1 COMPLETED

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.

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2013-09
Completion	2013-10

Conditions

Growth Disorder
Healthy

Interventions

Norditropin® FlexPro® pen
Genotropin Pen®

Primary outcomes

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
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
Maximum IGF-I effect (Emax) — Over a 96-hour sampling period

Countries

United States