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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: August 17, 2016
Last verified: January 2016
Results First Received: January 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy Volunteer
Interventions: Drug: oseltamivir [Tamiflu]
Drug: rimantadine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at a single center in the United States from 04 August 2009 to 28 September 2009. A total of 40 participants were screened.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 40 participants, 24 participants were enrolled.

Reporting Groups
  Description
Oseltamivir; Rimantadine; Oseltamivir + Rimantadine Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.

Participant Flow:   Overall Study
    Oseltamivir; Rimantadine; Oseltamivir + Rimantadine  
STARTED     24  
Oseltamivir     24  
Rimantadine     22  
Oseltamivir + Rimantadine     21  
COMPLETED     21  
NOT COMPLETED     3  
Withdrawal by Subject                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Oseltamivir; Rimantadine; Oseltamivir + Rimantadine Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.

Baseline Measures
    Oseltamivir; Rimantadine; Oseltamivir + Rimantadine  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean (Standard Deviation)
  33.5  (7.34)  
Gender  
[units: participants]
 
Female     3  
Male     21  



  Outcome Measures
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1.  Primary:   Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate   [ Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5 ]

2.  Primary:   Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine   [ Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5 ]

3.  Secondary:   Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate   [ Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5 ]

4.  Secondary:   Maximum Plasma Concentration (Cmax) of Rimantadine   [ Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5 ]

5.  Secondary:   Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)   [ Time Frame: Up to 11 weeks ]

6.  Secondary:   Number of Participants With Abnormal Vital Signs   [ Time Frame: Screening (Days -28 to -2); pre-dose and 2h post-dose on D1 and D5 of each treatment period; at Follow-up visit (10 -14 days after last dose) for blood pressure and HR; Screening; Day -1 of each treatment period; Follow-up visit for temperature ]

7.  Secondary:   Number of Participants With Marked Abnormality in Laboratory Parameters   [ Time Frame: Screening; Day -1 and Day 5 (pre-dose) of each treatment period; Follow-up visit ]

8.  Secondary:   Number of Participants With Clinically Significant or Treatment Related Changes in Electrocardiogram (ECG)   [ Time Frame: Screening; pre-dose on Day 1 and Day 5 of each treatment period; Follow-up visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 61 6878333
e-mail: global.trial_information@roche.com



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
Results First Received: January 5, 2016
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration