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This study has been withdrawn prior to enrollment.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

October 4, 2007
May 27, 2010
October 2007
October 2007   (final data collection date for primary outcome measure)
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 ]
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. ]
Complete list of historical versions of study NCT00540501 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2. Period 2-4 Day 1-3. [ Time Frame: Period 2-4 Day 1-3 ]
  • Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 Period 1, 3 & 4 Day 1-3. [ Time Frame: Period 1, 3 & 4 Day 1-3. ]
  • Safety:labs, vitals, ECGs & AEs. [ Time Frame: Period 1-4, Days 1-4. ]
Not Provided
Not Provided
 
A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects
Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
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 50mg/hour
    Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours
    Intervention: Drug: Oseltamivir and Intravenous Zanamivir
  • Experimental: Zanamivir IV 50mg/hour
    Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)
    Intervention: Drug: Oseltamivir and Intravenous Zanamivir
  • Experimental: Oseltamivir 150mg and zanamivir 600mg
    Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h
    Intervention: Drug: Oseltamivir and Intravenous Zanamivir
  • Active Comparator: Oseltamivir 150mg
    Oseltamivir 150mg PO q12h for 3 days
    Intervention: Drug: Oseltamivir and Intravenous Zanamivir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00540501
NAI108166
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP