Status:
COMPLETED
Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects
Lead Sponsor:
Manjunath Prakash Pai
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Obesity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
One in three Americans are obese. Obese subjects may or may not need higher doses of the anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the FDA approved dose o...
Detailed Description
The incidence of obesity has increased dramatically over the past two decades in the United States (US). Twenty-five percent of adult Americans are now classified as obese. Obesity is associated with ...
Eligibility Criteria
Inclusion
- males and females, 18 to 50 years of age
- non-smoking or light-smoking (≤5 cigarettes per day) volunteers
- BMI ≥ 40 kg/m2
- female subjects of childbearing potential either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap,condom) or agree to abstain from sex from time of pre-study screening, during entire study period and 1 week following the study period.
Exclusion
- history of significant hypersensitivity reaction to oseltamivir
- history of gastric bypass surgical procedure
- history of significant clinical illness requiring pharmacological management
- abnormal serum electrolyte or complete blood count requiring further clinical work-up
- transaminases (AST or ALT) \>2.5 x upper limit of normal
- estimated creatinine clearance \<50 mL/min (Cockcroft-Gault equation)
- positive urine pregnancy test (if female)
- abnormal electrocardiogram (ECG) as judged by study physician
- unable to tolerate venipuncture and multiple blood draws
- clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01179919
Start Date
July 1 2010
End Date
December 1 2010
Last Update
February 9 2017
Active Locations (1)
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1
TKL Research
Paramaus, New Jersey, United States, 07652