Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)|
|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|