| December 27, 2006 |
| November 29, 2007 |
| August 2006 |
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- 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.
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| Same as current |
| Complete list of historical versions of study NCT00416962 on ClinicalTrials.gov Archive Site |
| To assess the safety and tolerability of twice daily oseltamivir and twice daily amantadine when given alone and when given in combination. |
| Same as current |
| |
| Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine |
| 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. |
This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers. |
| |
| Phase I |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
| Healthy |
- Drug: amantadine hydrochloride
- Drug: oseltamivir phosphate
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| |
| Morrison D, Roy S, Rayner C, Amer A, Howard D, Smith JR, Evans TG. A randomized, crossover study to evaluate the pharmacokinetics of amantadine and oseltamivir administered alone and in combination. PLoS ONE. 2007 Dec 12;2(12):e1305. |
| |
| Completed |
| 18 |
| December 2006 |
|
Inclusion Criteria:
Exclusion Criteria:
- Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as those who report tobacco use or have a urine cotinine greater than 500 ng/mL
- Female subjects who are pregnant or lactating
- Participation in any clinical investigation involving medical intervention within 4 week prior to study start.
- Donation or loss of ≥ 400 mL of blood within 8 weeks prior to study start, or longer if required by local regulation.
- Significant illness within 2 weeks before study start.
- A past personal or close family medical history of clinically significant ECG abnormalities or of a prolonged QT-interval syndrome.
- History of autonomic dysfunction (for example, history of fainting).
- History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated),
- History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or to similar drugs.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pancreatic, hepatic, hematological, immunological, or neurological disorders.
Other protocol-defined inclusion/exclusion criteria may apply |
| Both |
| 18 Years to 45 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00416962 |
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| CSYO380A2101 |
| Novartis |
| Hoffmann-La Roche |
| Principal Investigator: |
Novartis |
Investigator site |
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| Novartis |
| November 2007 |