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

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Oseltamivir and Intravenous Zanamivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540501

NAI108166

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Oseltamivir 150mg and zanamivir 50mg/hour

Experimental group

Description:

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

Treatment:

Drug: Oseltamivir and Intravenous Zanamivir

Zanamivir IV 50mg/hour

Experimental group

Description:

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

Treatment:

Drug: Oseltamivir and Intravenous Zanamivir

Oseltamivir 150mg and zanamivir 600mg

Experimental group

Description:

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

Treatment:

Drug: Oseltamivir and Intravenous Zanamivir

Oseltamivir 150mg

Active Comparator group

Description:

Oseltamivir 150mg PO q12h for 3 days

Treatment:

Drug: Oseltamivir and Intravenous Zanamivir