Status:
COMPLETED
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This open label, randomized, three-period crossover study will evaluate the effect of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu and rimantadine. Hea...
Eligibility Criteria
Inclusion
- Adults, aged 18 to 45 years
- Healthy as judged by general physical examination, medical history, vital signs, 12-lead ECG and laboratory tests
- Body Mass Index (BMI) 18-34 kg/m2
- Willing not to participate in any other trial including an investigational drug for 3 months following the last dose
- Male subjects must agree to use a barrier contraception during the study and for 3 months after discontinuation of treatment
- Female subjects of non-child bearing potential or under effective contraception who are either post-menopausal, surgically sterile, or who agree to use barrier contraception during the whole study in addition to an intrauterine device or hormonal contraception for at least 3 months prior to 1st dose, during the study and for 3 months after discontinuation of treatment
Exclusion
- History of or current clinically significant disease or disorder
- Positive Hepatitis B, Hepatitis C, HIV 1 or 2 test result
- Positive pregnancy test or lactating women
- Clinically relevant history of allergy or hypersensitivity
- Clinically relevant history of abuse of alcohol or other drugs; tobacco smoking is allowed (\</= 10 cigarettes a day or equivalent of tobacco in cigars or pipe)
- Any major illness within 30 days prior to screening examination
- Administration of any medication during the 7 days prior to drug administration, except for paracetamol and aspirin (up to 48 hours before first dose) and oral contraceptives
- Participation in a clinical study with an investigational drug within 3 months prior to study day 1
- Donation or loss of more than 500 mL of blood within the 3 months prior to study day 1
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01172847
Start Date
August 1 2009
End Date
February 1 2010
Last Update
August 19 2016
Active Locations (1)
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1
Little Rock, Arkansas, United States, 72204