Last updated: 11/04/2018 09:21:56
A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects
GSK study ID
NAI108166
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
Trial description: 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
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Oseltamivir carboxylate levels: Cmax and AUC(0-12)-
Timeframe: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.
Secondary outcomes:
Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.
Timeframe: Period 2-4 Day 1-3
Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .
Timeframe: Period 1, 3 & 4 Day 1-3
Safety:labs, vitals, ECGs & AEs.
Timeframe: Period 1-4, Days 1-4.
Interventions:
Drug: Oseltamivir and Intravenous Zanamivir
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
zanamivir
Collaborators
GSK
Study date(s)
June 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- 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.
- Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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