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

GlaxoSmithKline

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Healthy Subjects

Interventions

Oseltamivir and Intravenous ZanamivirDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Oseltamivir carboxylate levels: Cmax and AUC(0-12)-

Time frame: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.

Secondary Outcomes

Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.

Time frame: Period 2-4 Day 1-3

Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .

Time frame: Period 1, 3 & 4 Day 1-3

Safety:labs, vitals, ECGs & AEs.

Time frame: Period 1-4, Days 1-4.

Data from ClinicalTrials.gov

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