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SEA-002
Pharmacologic study of Oseltamivir in Healthy Volunteers
Study Summary
Design: Phase I, randomized, single-center, international clinical trial, designed to find the most cost-effective practicable treatment regimen for avian influenza in healthy volunteers.
Population: A minimum of 8 and maximum of 32 subjects (male and female):
- All participants will be healthy volunteers
- Age range of participants are between 18 – 50 years of age
Study Duration: 4 months
Study Objectives:
- To assess the use of loading dose oseltamivir; to describe the pharmacokinetics, tolerability, and toxicity of oseltamivir loading dose regimens at four increasing dose levels of oseltamivir.
- To assess the concomitant use of probenecid; to assess tolerability and safety and to characterize the pharmacokinetic interaction with oseltamivir at four increasing dose levels of oseltamivir.
- Characterize the pharmacokinetic properties of oseltamivir in Thai subjects.
Primary Endpoint: To determine the optimum treatment for avian influenza by defining the mathematical relationship between the concentration of drugs in body fluids and the virological response in patients.
Study Site: Bangkok Hospital for Tropical Diseases, Faculty of Tropical Medicine, Bangkok, Thailand
Principal Investigator: Associate Professor Yupaporn Wattanagoon
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