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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Subjects

Intervention: Oseltamivir and Intravenous Zanamivir (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

Official title: Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

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

Safety:labs, vitals, ECGs & AEs.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: October 2007
Last updated: May 27, 2010

Page last updated: August 23, 2015

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