Healthy Subjects
Conditions
Keywords
zanamivir,, influenza virus,, healthy volunteer,, PK, drug interaction,, IV, and oseltamivir.
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
Interventions
DRUGOseltamivir and Intravenous Zanamivir
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Outcome results
None listed