A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: rimantadine; Drug: oseltamivir [Tamiflu]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01172847

NP22770

2009-012742-23

Details and patient eligibility

About

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. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between treatments. Anticipated time on study is up to 11 weeks.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

24 participants in 3 patient groups

A

Active Comparator group

Treatment:

Drug: oseltamivir [Tamiflu]

B

Active Comparator group

Treatment:

Drug: rimantadine

C

Experimental group

Treatment:

Drug: rimantadine

Drug: oseltamivir [Tamiflu]