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.
1 other identifier
interventional
18
1 country
1
Brief Summary
This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 27, 2006
CompletedFirst Posted
Study publicly available on registry
December 28, 2006
CompletedNovember 30, 2007
November 1, 2007
December 27, 2006
November 29, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
To assess the safety and tolerability of twice daily oseltamivir and twice daily amantadine when given alone and when given in combination.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male or female subjects aged 18 to 45 years, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests
- Vital signs within the following ranges:
- oral body temperature 35.0 - 37.5°C
- systolic blood pressure 90 - 140 mm Hg
- diastolic blood pressure 50 - 90 mm Hg
- pulse rate 40 - 90 bpm
- Body mass index must be within 18 - 30 kg/m2. Subjects must weigh at least 50 kg.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Hoffmann-La Rochecollaborator
Study Sites (1)
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080, United States
Related Publications (1)
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. doi: 10.1371/journal.pone.0001305.
PMID: 18074029DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Investigator site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 27, 2006
First Posted
December 28, 2006
Study Start
August 1, 2006
Study Completion
December 1, 2006
Last Updated
November 30, 2007
Record last verified: 2007-11