At a glance
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Phase I, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Oseltamivir in Healthy Obese Thai Adult Subjects
In Brief
A Phase 1 clinical trial evaluating oseltamivir for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This study is planned to characterize the pharmacokinetic properties of oseltamivir and the active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for the optimum oseltamivir treatment regimens for severe influenza. It is also a prompt response to a new era influenza plan along with recognition of growing numbers of obese persons. The study findings will be available for a future management plan in dealing with this virus that is transmitted easily from person to person and has shown substantial antigenic changes over time. The primary focus of statistical analysis is to verify the effect of obesity on oseltamivir/oseltamivir carboxylate pharmacokinetics as measured by oseltamivir carboxylate Cmax, AUC (0-12), AUC (0-24), C12, λz, and t1/2 and oseltamivir Cmax, AUC (0-12), and C12.
Study Details
Timeline
Interventions
oseltamivir 150 mg single oral dose oseltamivir 75 mg single oral dose