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Oseltamivir Pharmacokinetics in Morbid Obesity

NCT01002729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-08-03

No results posted yet for this study

Summary

This trial asks the question: do people of much greater than average body weight need more of a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given to people who have influenza, and currently is also being used to fight the new H1N1 influenza. Some people of larger than average body weight require larger amounts of drugs to see the same effects as others of an average body weight. No studies have ever been conducted looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis states that those of an above average body weight will have different amounts of drug in their blood than those of people of normal body weight if they are given the normal amount prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half of the people will be of normal body weight and the others will be of a much higher than normal body weight. Using blood samples the investigators will determine if the amounts of oseltamivir are significantly lower in the blood of patients in the above normal body weight group.

Conditions

  • Morbid Obesity

Interventions

OTHER

Patients with a BMI < 30 given Oseltamivir

Patients with a BMI \< 30 given Oseltamivir

OTHER

Patients with a BMI > 40 given Oseltamivir

Patients with a BMI \> 40 given Oseltamivir

Sponsors & Collaborators

  • Canadian Center for Vaccinology

    collaborator OTHER

  • Nova Scotia Health Authority

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • IWK Health Centre

    lead OTHER

Principal Investigators

  • Lucas M Thorne-Humphrey, BSC Pharm · Dalhousie Unviersity, Captial District Health Authority

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT01002729 on ClinicalTrials.gov