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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amantadine hydrochloride | Drug | |||
| oseltamivir phosphate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of twice daily oseltamivir and twice daily amantadine when given alone and when given in combination. |
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Inclusion Criteria:
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:
Female subjects of child bearing potential must be using double-barrier local contraception (for example, intra-uterine device plus condom, or spermicidal gel plus condom) or have been surgically sterilized at least 6 months prior before study start, with supportive clinical documentation OR Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
Body mass index must be within 18 - 30 kg/m2. Subjects must weigh at least 50 kg.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Hanover | New Jersey | 07936-1080 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18074029 | Derived | 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. |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| D009930 |
| Organic Chemicals |
| D000081 | Acetamides |
| D000577 | Amides |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |