A Pharmacokinetic Comparison of Oral Solution and Tablet Formulations of Favipiravir 200 mg in Healthy Thai Volunteers under Fasting Conditions
Phase 1
- Conditions
- Healthy Thai volunteersPharmacokinetic, Favipiravir, Healthy Thai volunteers
- Registration Number
- TCTR20210903002
- Lead Sponsor
- Chulabhorn Royal Academy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
1. Thai male/female healthy volunteers, 18-55 years of age
2. Normal hematologic, renal and liver function
Exclusion Criteria
1. Known hypersensitivity to favipiravir, any other similar class of drugs or its components
2. Past medical history of renal and hepatic insufficiency
3. Subject has a history of any illness that, in the opinion of principal investigator or designated physicians, might confound the result of the study or pose an additional risk in administering study drug to the subject.
4. Have history of drug abuse in the last 12 months
5. Female subject is pregnant or breast feeding.
6. Difficult swallowing the study drug
7. Have positive RT-PCR for nasopharyngeal swab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of favipiravir administered in oral solution (favipiravir CRA syrup) and in tablets (AVIGAN) D1 and D8 for period 1 and 2 Serum favipiravir concentration level
- Secondary Outcome Measures
Name Time Method Safety during study period safety questionnaire, laboratory measurement