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NCT01172847 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers
A Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01172847: Completed Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
NCT01172847 is a Phase 1 study of Healthy Volunteer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01172847, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.
Conditions Studied
Interventions
- DRUG oseltamivir [Tamiflu]
- DRUG rimantadine
Study Locations (1)
Arkansas
- - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT01172847 record still lists
NCT01172847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which oseltamivir [Tamiflu] is the first listed.
NCT01172847 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT01172847 about?
NCT01172847 is a clinical study titled "A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers". 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...
What is the current status of trial NCT01172847?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-08. Estimated completion is 2010-02.
What conditions does trial NCT01172847 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01172847?
The interventions under investigation include: oseltamivir [Tamiflu] (DRUG), rimantadine (DRUG).
Who is sponsoring clinical trial NCT01172847?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01172847 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01172847's enrollment target sits among peer trials
24 85th of 112 higher than 20 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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