NCT01494779

Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: Male
• Age: 18 Years – 32 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).

Detailed description

Secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between groups.

Conditions

• GH Deficiency (GHD)
• Growth Retardation

Interventions

Type	Name	Description
DRUG	Somatropin	single subcutaneous dose of 5mg
DRUG	Somatropin	single subcutaneous dose of 5mg

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2011-12-19
• Last updated: 2012-09-25

Locations

1 site across 1 country: Brazil