Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers
Recruiting
Phase 1
Interventional Study
Infectious Disease
Pharmacology
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 39 (estimated)
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France · Government
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About This Trial
FAVIDOSE trial is a Phase I randomized, double blind controlled, monocentric, dose escalation clinical trial. The primary purpose of this trial is to evaluate tolerance of high doses of favipiravir for 14 days in healthy volunteers. This trial also looks to characterize favipiravir pharmacokinetics in blood and favipiravir levels in sperm. A pharmacogenetics analysis will be conducted in an attemp…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Man between 50 and 75 years old without any desire to have children or woman between 18 and 75 years old ;
2. Subject considered healthy after a thorough general examination (questioning, physical examination);
3. For men: acceptance of semen collection by masturbation;
4. Fo…
Contacts