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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir 150mg and zanamivir 50mg/hour | Experimental | Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours |
|
| Zanamivir IV 50mg/hour | Experimental | Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg) |
|
| Oseltamivir 150mg and zanamivir 600mg | Experimental | Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h |
|
| Oseltamivir 150mg | Active Comparator | Oseltamivir 150mg PO q12h for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir and Intravenous Zanamivir | Drug | 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. |
| 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. |
| 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 | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Safety:labs, vitals, ECGs & AEs. |
| Period 1-4, Days 1-4. |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |