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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: oseltamivir [Tamiflu] (Drug); rimantadine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: An Open-label, Multiple Dose, Randomized, Three-period Crossover Study in Healthy Subjects to Evaluate the Effect of Co-administration of Oseltamivir (Ro 64-0796) 75 mg Twice Daily and Rimantadine 100 mg Twice Daily on the Pharmacokinetic Properties of Oseltamivir and Rimantadine.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Effect of rimantadine on the pharmacokinetics of oseltamivir: AUC, Cmax

Effect of oseltamivir on the pharmacokinetics of rimantadine: AUC, Cmax

Secondary outcome: Safety and tolerability: Adverse events, laboratory parameters, vital signs, ECG

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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 ( - 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

Locations and Contacts

Little Rock, Arkansas 72204, United States
Additional Information

Starting date: August 2009
Last updated: August 17, 2015

Page last updated: August 23, 2015

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