A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects
- Registration Number
- NCT00540501
- Lead Sponsor
- GlaxoSmithKline
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oseltamivir 150mg and zanamivir 50mg/hour Oseltamivir and Intravenous Zanamivir Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours Oseltamivir 150mg Oseltamivir and Intravenous Zanamivir Oseltamivir 150mg PO q12h for 3 days Zanamivir IV 50mg/hour Oseltamivir and Intravenous Zanamivir Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg) Oseltamivir 150mg and zanamivir 600mg Oseltamivir and Intravenous Zanamivir Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h
- Primary Outcome Measures
Name Time Method Oseltamivir carboxylate levels: Cmax and AUC(0-12)- Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.
- Secondary Outcome Measures
Name Time Method Safety:labs, vitals, ECGs & AEs. Period 1-4, Days 1-4. Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2. Period 2-4 Day 1-3 Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 . Period 1, 3 & 4 Day 1-3