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

NCT ID: NCT01172847

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-02-28

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. 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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

oseltamivir [Tamiflu]

Intervention Type: DRUG

multiple oral doses

B

Group Type: ACTIVE_COMPARATOR

rimantadine

Intervention Type: DRUG

multiple oral doses

C

Group Type: EXPERIMENTAL

oseltamivir [Tamiflu]

Intervention Type: DRUG

multiple oral doses

rimantadine

Intervention Type: DRUG

multiple oral doses

Interventions

oseltamivir [Tamiflu]

multiple oral doses

Intervention Type: DRUG

rimantadine

multiple oral doses

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

2009-012742-23

Identifier Type: -

Identifier Source: secondary_id

NP22770

Identifier Type: -

Identifier Source: org_study_id