NCT01049763

Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects

Phase I, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Oseltamivir in Healthy Obese Thai Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: South East Asia Infectious Disease Clinical Research Network · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label, cross-over, randomized pharmacokinetic study conducted in approximately 12 obese and 12 non obese adult subjects at one study center in Thailand. Subjects will receive 2 regimens in a random sequence for 2 visits. 1. Regimen A; 75 mg single dose. 2. Regimen B; 150 mg single dose. All dosing will be supervised and documented. Subjects will have 2 hospitalizations to complete visit 2 and visit 3 in their assigned sequence within each. Each visit will require hospitalization for about 40 hours (2 nights and 2 days). The subject will be randomized to receive either regimen A or B on first admission (visit 2). Treatment allocation will be performed using computer-generated list of random permutations of AB sequence. Subjects who received regimen A will receive regimen B on second admission and vice versa, with more than 3 days wash out period in between. Subjects will return to the study centre for a follow-up visit 7-10 days after completing the last dosing assessments or withdrawing from the study. The total duration of study participation will be approximately 4 weeks from screening through follow-up. Assessment of the safety profile will be done after each admission by the investigating team before proceeding to the other regimen.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	oseltamivir	oseltamivir 150 mg single oral dose oseltamivir 75 mg single oral dose

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2010-01-14
• Last updated: 2010-10-08

Locations

1 site across 1 country: Thailand