Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
Condition: Bioequivalence
Intervention: FAVIRA 200 MG Film Tablet; AVIGAN 200 MG Film Tablets
Intervention description: FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey.; AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan
Intervention MeSH terms: Favipiravir
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19 drug treatment; Antiviral Agents; Favipiravir; Novagenix; Farmagen

Summary:

      A single dose of Reference product containing 200 mg favipiravir and a single dose of Test
      product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at
      room temperature, in each period under fasting conditions with current pandemic precautions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy Caucasian male subjects aged between 20 and 40 years,

          2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink
             coffee during the study period,

          3. Two Negative Covid-19 PCR test results.

          4. Negative alcohol breath test results,

          5. Normal physical examination at screening visit,

          6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in
             the desirable range according to the age,

          7. Ability to communicate adequately with the investigator himself or his
             representatives,

          8. Ability and agreement to comply with the study requirements,

          9. Normal blood pressure and heart rate measured under stabilised conditions at the
             screening visit after at least 5 minutes of rest under supine position: SBP within 100
             to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm,

         10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of
             rest,

         11. Laboratory results within normal range or clinically non-significant (CBC, glucose,
             urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium,
             calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein
             and urinalysis), drug addiction scanning in urine results in negative (amphetamine,
             barbiturate, benzodiazepine, cannabinoid, cocaine, opiate),

         12. Understanding of the study and agreement to give a written informed consent according
             to section 20.3.

         13. Understanding of that he and his partner will use a practice adequate contraception
             during the study and at least 7 days after the study.

         14. Volunteer's compliance with isolation rules defined at study protocol.

        Exclusion Criteria:

          1. Who have atopic constitution or asthma or known allergy for favipiravir and/or any
             other ingredients of the products.

          2. Who have positive Covid-19 PCR test result.

          3. Any history or presence of clinical relevance of cardiovascular, neurological,
             musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary,
             endocrinological, metabolism or psychiatric disease, any type of porphyria.

          4. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first
             drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10
             mmHg occurs between sitting/supine to standing position subject will be excluded (if
             it deemed necessary by the investigator),

          5. Presence or history of malabsorption or any gastrointestinal surgery except
             appendectomy or except herniotomy.

          6. Subjects who have given more than 400 mL blood within the last two months before the
             first drug administration and subjects who have participated to any drug research
             within the last two months before the first drug administration.

          7. Subjects suspected to have a high probability of non-compliance to the study procedure
             and/or completion of the study according to the investigator's judgement.

          8. Subjects who used any of prescribed systemic or topical medication (including OTC
             medication) within 2 weeks (or six elimination half lives of this medication,
             whichever is longer) before the initiation of the study (except single doses of
             analgesics which have no drug interaction with study product).

          9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the
             study medication.

         10. History of allergic response to heparin.

         11. Subjects who have any chronic disease which might interfere with absorption,
             distribution, metabolism or excretion of the drug.

         12. Subjects who regular consumed of beverages or food containing methylxanthines (e.g.
             coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg
             methylxanthines per day.

         13. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug
             administration, during the study.

         14. History of drug abuse.

         15. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or
             10 units per week and/or positive alcohol breath test results (Note: one unit of
             alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits).

         16. Positive blood test for HBV, HCV and HIV.

         17. Who have relationship to the investigator.

         18. Who are not suitable to any of inclusion criteria.

         19. History of difficulty of swallowing.

         20. Intake of depot injectable solutions (including study medications) within 6 months
             before start of the study.

         21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before
             start of the study.

         22. Special diet due to any reason, e.g. vegetarian.