Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions

NCT ID: NCT04406194

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2020-06-19

Brief 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.

Detailed Description

Favipiravir is a drug with a mechanism of action different from that of the existing influenza antiviral drugs and effective against all types and sub-types of human influenza A, B and C viruses in vitro, showing anti-viral activity against various influenza virus strains including avian and swine viruses. Favipiravir also has shown anti-viral activity even against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The mechanism of action of favipiravir is the selective inhibition of RNA polymerase by favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to antiviral activity.

Conditions

Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

FAVICOVIR then AVIGAN

Participants first received Favicovir 200 mg FT manufactured by Atabay in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state.

Group Type: EXPERIMENTAL

FAVICOVIR 200 mg Film Tablet

Intervention Type: DRUG

FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.

AVIGAN 200 mg Film Tablets

Intervention Type: DRUG

AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.

AVIGAN then FAVICOVIR

Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state.

Group Type: EXPERIMENTAL

FAVICOVIR 200 mg Film Tablet

Intervention Type: DRUG

FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.

AVIGAN 200 mg Film Tablets

Intervention Type: DRUG

AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.

Interventions

FAVICOVIR 200 mg Film Tablet

FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.

Intervention Type: DRUG

AVIGAN 200 mg Film Tablets

AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.

Intervention Type: DRUG

Other Intervention Names

Favipiravir 200 MG FT; Favipiravir 200 mg FT

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

18. History of difficulty of swallowing.

19. Intake of depot injectable solutions (including study medications) within 6 months before start of the study.

20. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.

21. Special diet due to any reason, e.g. vegetarian.

Exclusion Criteria

1. Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products.

2. 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.

3. 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),

4. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.

5. 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.

6. 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.

7. 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).

8. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.

9. History of allergic response to heparin.

10. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.

11. 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.

12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study.

13. History of drug abuse.

14. 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).

15. Positive blood test for HBV, HCV and HIV.

16. Who have relationship to the investigator.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novagenix Bioanalytical Drug R&D Center

NETWORK

Sponsor Role: collaborator

Farmagen Ar-Ge Biyot. Ltd. Sti

NETWORK

Sponsor Role: collaborator

Atabay Kimya Sanayi Ticaret A.S.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muradiye Nacak, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Farmagen Ar-Ge Biyot. Ltd. Sti

Locations

Novagenix Drug R&D Center

Akyurt, Ankara, Turkey (Türkiye)

Farmagen Ar-Ge Biyot. Ltd. Sti.

Şahinbey, Gaziantep, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NOV2020/1917

Identifier Type: -

Identifier Source: org_study_id