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

Study Overview
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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

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Oseltamivir and Intravenous Zanamivir


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oseltamivir 150mg and zanamivir 50mg/hour<br>Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours | Drug: Oseltamivir and Intravenous Zanamivir<br>* 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.<br>|
| Experimental: Zanamivir IV 50mg/hour<br>Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg) | Drug: Oseltamivir and Intravenous Zanamivir<br>* 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.<br>|
| Experimental: Oseltamivir 150mg and zanamivir 600mg<br>Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h | Drug: Oseltamivir and Intravenous Zanamivir<br>* 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.<br>|
| Active Comparator: Oseltamivir 150mg<br>Oseltamivir 150mg PO q12h for 3 days | Drug: Oseltamivir and Intravenous Zanamivir<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Safety:labs, vitals, ECGs & AEs. |  | Period 1-4, Days 1-4. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zanamivir,, influenza virus,, healthy volunteer,, PK, drug interaction,, IV, and oseltamivir.