Healthy Thai volunteers Pharmacokinetic, Favipiravir, Healthy Thai volunteers
Conditions
Interventions
Favipiravir solution (Favipiravir CRA syrup) 200 mg/15 ml,Favipiravir (AVIGAN) 200 mg/tab
Experimental Drug,Active Comparator Drug
Favipiravir solution,Favipiravir tablet (AVIGAN)
Sponsors
Chulabhorn Royal Academy
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Thai male/female healthy volunteers, 18-55 years of age 2. Normal hematologic, renal and liver function
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety during study period safety questionnaire, laboratory measurement | — |
Countries
Thailand
Contacts
Public ContactTeerapat Ungtrakul
Chulabhorn Royal Academy
Outcome results
None listed