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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01172847
First received: July 29, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This open label, randomized, three-period crossover study will evaluate the effe ct of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmaco kinetics of Tamiflu and rimantadine. Healthy volunteers will receive multiple or al doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, wi th a minimum wash-out period of 7 days between treatments. Anticipated time on s tudy is up to 11 weeks.


Condition Intervention Phase
Healthy Volunteer
Drug: oseltamivir [Tamiflu]
Drug: rimantadine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of rimantadine on the pharmacokinetics of oseltamivir: AUC, Cmax [ Time Frame: Day 5 (pre-dose and during 12 hours post-dose) ] [ Designated as safety issue: No ]
  • Effect of oseltamivir on the pharmacokinetics of rimantadine: AUC, Cmax [ Time Frame: Day 5 (pre-dose and during 12 hours post-dose) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability: Adverse events, laboratory parameters, vital signs, ECG [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: oseltamivir [Tamiflu]
multiple oral doses
Active Comparator: B Drug: rimantadine
multiple oral doses
Experimental: C Drug: oseltamivir [Tamiflu]
multiple oral doses
Drug: rimantadine
multiple oral doses

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172847

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01172847     History of Changes
Other Study ID Numbers: NP22770, 2009-012742-23
Study First Received: July 29, 2010
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rimantadine
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014