NCT01401244

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

A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	somatropin	A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
DRUG	somatropin	A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

Timeline

• Start date: 2011-07-14
• Primary completion: 2011-09-27
• Completion: 2011-09-27
• First posted: 2011-07-25
• Last updated: 2017-02-24

Locations

1 site across 1 country: United States