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A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects

NCT ID: NCT00540501

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-10-31

Brief Summary

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This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Detailed Description

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Conditions

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Healthy Subjects

Keywords

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zanamivir, influenza virus, healthy volunteer, PK, drug interaction, IV, and oseltamivir.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oseltamivir 150mg and zanamivir 50mg/hour

Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours

Group Type EXPERIMENTAL

Oseltamivir and Intravenous Zanamivir

Intervention Type DRUG

Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.

Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.

Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.

Zanamivir IV 50mg/hour

Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)

Group Type EXPERIMENTAL

Oseltamivir and Intravenous Zanamivir

Intervention Type DRUG

Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.

Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.

Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.

Oseltamivir 150mg and zanamivir 600mg

Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h

Group Type EXPERIMENTAL

Oseltamivir and Intravenous Zanamivir

Intervention Type DRUG

Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.

Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.

Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.

Oseltamivir 150mg

Oseltamivir 150mg PO q12h for 3 days

Group Type ACTIVE_COMPARATOR

Oseltamivir and Intravenous Zanamivir

Intervention Type DRUG

Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.

Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.

Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.

Interventions

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Oseltamivir and Intravenous Zanamivir

Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.

Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.

Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
* Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control.

Exclusion Criteria

* Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

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Thailand

Other Identifiers

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NAI108166

Identifier Type: -

Identifier Source: org_study_id