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| Name | Class |
|---|---|
| Canadian Center for Vaccinology | OTHER |
| Nova Scotia Health Authority | OTHER |
| Dalhousie University | OTHER |
| Hoffmann-La Roche |
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This trial asks the question: do people of much greater than average body weight need more of a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given to people who have influenza, and currently is also being used to fight the new H1N1 influenza. Some people of larger than average body weight require larger amounts of drugs to see the same effects as others of an average body weight. No studies have ever been conducted looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis states that those of an above average body weight will have different amounts of drug in their blood than those of people of normal body weight if they are given the normal amount prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half of the people will be of normal body weight and the others will be of a much higher than normal body weight. Using blood samples the investigators will determine if the amounts of oseltamivir are significantly lower in the blood of patients in the above normal body weight group.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with a BMI < 30 given Oseltamivir | Other | Patients with a BMI < 30 given Oseltamivir | ||
| Patients with a BMI > 40 given Oseltamivir | Other | Patients with a BMI > 40 given Oseltamivir |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Drug Concentration | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
Adjusted body weight = Ideal body weight + [0.4 (Actual Bodyweight-Ideal Body Weight)]
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| Name | Affiliation | Role |
|---|---|---|
| Lucas M Thorne-Humphrey, BSC Pharm | Dalhousie Unviersity, Captial District Health Authority | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Vaccine Challenge Unit, IWK Health Center | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21700623 | Result | Thorne-Humphrey LM, Goralski KB, Slayter KL, Hatchette TF, Johnston BL, McNeil SA; 2009 OPTIMO Study Group. Oseltamivir pharmacokinetics in morbid obesity (OPTIMO trial). J Antimicrob Chemother. 2011 Sep;66(9):2083-91. doi: 10.1093/jac/dkr257. Epub 2011 Jun 23. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| INDUSTRY |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |