Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine
|ClinicalTrials.gov Identifier: NCT00416962|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : November 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: amantadine hydrochloride Drug: oseltamivir phosphate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||August 2006|
|Study Completion Date :||December 2006|
- 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.
- To assess the safety and tolerability of twice daily oseltamivir and twice daily amantadine when given alone and when given in combination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416962
|United States, New Jersey|
|Novartis Investigative Site|
|East Hanover, New Jersey, United States, 07936-1080|
|Principal Investigator:||Novartis||Investigator site|