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

NCT01049763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-10-08

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

oseltamivir

oseltamivir 150 mg single oral dose oseltamivir 75 mg single oral dose

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • South East Asia Infectious Disease Clinical Research Network

    lead NETWORK

Principal Investigators

  • Podjanee Jittmala, MD · Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University

  • Sasithon Pukrittayakamee, Professor · Mahidol University

  • Pratap Singhasivanon, A/Professor · Mahidol University

  • Nick White, Professor · Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Bangkok, Thailand

  • Nick Day, Professor · Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Bangkok, Thailand

  • Niklas Lindegardh, A/Professor · Clinical Pharmacology Laboratory Faculty of Tropical Medicine, Mahidol University Bangkok, Thailand

  • Bob Taylor, MD · Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University Bangkok, Thailand

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2010-10-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01049763 on ClinicalTrials.gov