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

Healthy Subjects Clinical Trial

Official title:

Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00540501
• Other study ID #: NAI108166
• Status: Withdrawn
• Phase: Phase 1
• First received: October 4, 2007
• Last updated: May 27, 2010
• Start date: October 2007
• Est. completion date: October 2007

Study information

• Verified date: May 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.		Period 2-4 Day 1-3	No
Secondary	Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .		Period 1, 3 & 4 Day 1-3	No
Secondary	Safety:labs, vitals, ECGs & AEs.		Period 1-4, Days 1-4.	No