Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine
This study has been completed.
Information provided by:
First received: December 27, 2006
Last updated: November 29, 2007
Last verified: November 2007
This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers.
Drug: amantadine hydrochloride
Drug: oseltamivir phosphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multiple Dose, Randomized, Three-Period Crossover Study in Healthy Volunteers to Evaluate the Effect of co-Administration of Amantadine 100 mg BID and Oseltamivir 75 mg BID on the Pharmacokinetic Properties of Amantadine and Oseltamivir.|
Resource links provided by NLM:
Drug Information available for: Amantadine hydrochloride Amantadine Oseltamivir Oseltamivir phosphateU.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- To characterize the pharmacokinetics of amantadine following twice daily administration alone or in combination with twice daily oseltamivir in healthy volunteers.
- To characterize the pharmacokinetics of oseltamivir following twice daily administration alone or in combination with twice daily amantadine in healthy volunteers.
Secondary Outcome Measures:
- To assess the safety and tolerability of twice daily oseltamivir and twice daily amantadine when given alone and when given in combination.
|Study Start Date:||August 2006|
|Study Completion Date:||December 2006|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416962
|United States, New Jersey|
|Novartis Investigative Site|
|East Hanover, New Jersey, United States, 07936-1080|
Sponsors and Collaborators
|Principal Investigator:||Novartis||Investigator site|