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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: November 3, 2014
Last verified: November 2014

July 29, 2010
November 3, 2014
August 2009
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01172847 on ClinicalTrials.gov Archive Site
Safety and tolerability: Adverse events, laboratory parameters, vital signs, ECG [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteer
  • Drug: oseltamivir [Tamiflu]
    multiple oral doses
  • Drug: rimantadine
    multiple oral doses
  • Active Comparator: A
    Intervention: Drug: oseltamivir [Tamiflu]
  • Active Comparator: B
    Intervention: Drug: rimantadine
  • Experimental: C
    Interventions:
    • Drug: oseltamivir [Tamiflu]
    • Drug: rimantadine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01172847
NP22770, 2009-012742-23
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP