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Clinical Trial 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.).


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01494779
Study type Interventional
Source L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Contact Alexandre Frederico, physian
Phone 55 19 3871-6399
Email alexandre@lalclinica.com.br
Status Not yet recruiting
Phase Phase 1
Start date March 2013
Completion date August 2013

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