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

This study has been withdrawn prior to enrollment.
(Contract agreement not reached)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00540501
First received: October 4, 2007
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Subjects
 Drug: Oseltamivir and Intravenous Zanamivir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Oseltamivir carboxylate levels: Cmax and AUC(0-12)- [ Time Frame: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2. [ Time Frame: Period 2-4 Day 1-3 ] [ Designated as safety issue: No ]
  • Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 . [ Time Frame: Period 1, 3 & 4 Day 1-3 ] [ Designated as safety issue: No ]
  • Safety:labs, vitals, ECGs & AEs. [ Time Frame: Period 1-4, Days 1-4. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2007
Estimated Study Completion Date: October 2007
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oseltamivir 150mg and zanamivir 50mg/hour
Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours
 Drug: Oseltamivir 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.

Other Name: Oseltamivir and Intravenous Zanamivir
Experimental: Zanamivir IV 50mg/hour
Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)
 Drug: Oseltamivir 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.

Other Name: Oseltamivir and Intravenous Zanamivir
Experimental: Oseltamivir 150mg and zanamivir 600mg
Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h
 Drug: Oseltamivir 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.

Other Name: Oseltamivir and Intravenous Zanamivir
Active Comparator: Oseltamivir 150mg
Oseltamivir 150mg PO q12h for 3 days
 Drug: Oseltamivir 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.

Other Name: Oseltamivir and Intravenous Zanamivir

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540501

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00540501     History of Changes
Other Study ID Numbers: NAI108166
Study First Received: October 4, 2007
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
zanamivir,
influenza virus,
healthy volunteer,
PK, drug interaction,
IV, and oseltamivir.

Additional relevant MeSH terms:
Zanamivir
Oseltamivir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013