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

NCT04400682 | Completed Phase 1 Results

• 2 other identifiers: NOV2020/1923FARGE 367
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Bioequivalence

Keywords

COVID-19 drug treatment; Antiviral Agents; Favipiravir; Novagenix; Farmagen

Outcome Measures

Primary Outcomes (2)

• AUC0-tlast

  AUC0-tlast of favipiravir will be obtained from plasma concentrations

  0 to 24 hours post dose

• Favipiravir Cmax

  Favipiravir Cmax Cmax of favipiravir will be obtained from plasma concentrations

  0 to 24 hours post dose

Secondary Outcomes (2)

• AUC0-inf of Favipiravir

  0 to 24 hours post dose

• Tmax of Favipiravir

  0 to 24 hours post dose

Study Arms (2)

FAVIRA then AVIGAN

EXPERIMENTAL

Participants first received Favira 200 mg FT manufactured by Novelfarma 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.

Drug: FAVIRA 200 MG Film Tablet; Drug: AVIGAN 200 MG Film Tablets

AVIGAN then FAVIRA

EXPERIMENTAL

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

Drug: FAVIRA 200 MG Film Tablet; Drug: AVIGAN 200 MG Film Tablets

Interventions

FAVIRA 200 MG Film Tablet DRUG

FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey.

Also known as: FAVIRA 200 MG FT

AVIGAN then FAVIRA; FAVIRA then AVIGAN

AVIGAN 200 MG Film Tablets DRUG

AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan

Also known as: AVIGAN 200 mg FT

AVIGAN then FAVIRA; FAVIRA then AVIGAN

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Caucasian male subjects aged between 20 and 40 years,
• Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period,
• Two Negative Covid-19 PCR test results.
• Negative alcohol breath test results,
• Normal physical examination at screening visit,
• 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,
• Ability to communicate adequately with the investigator himself or his representatives,
• Ability and agreement to comply with the study requirements,
• 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,
• Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest,
• 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),
• Understanding of the study and agreement to give a written informed consent according to section 20.3.
• Understanding of that he and his partner will use a practice adequate contraception during the study and at least 7 days after the study.
• Volunteer's compliance with isolation rules defined at study protocol.

You may not qualify if:

• Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products.
• Who have positive Covid-19 PCR test result.
• 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.
• 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),
• Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
• 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.
• 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.
• 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).
• Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
• History of allergic response to heparin.
• Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
• 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.
• Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study.
• History of drug abuse.
• 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).

Sponsors & Collaborators

• Novelfarma Ilaç San. ve Tic. Ltd. Sti.: lead
• Novagenix Bioanalytical Drug R&D Center: collaborator
• Farmagen Ar-Ge Biyot. Ltd. Sti: collaborator

Study Sites (2)

Novagenix Drug R&D Center

Akyurt, Ankara, 06970, Turkey (Türkiye)

Location

Farmagen Ar-Ge Biyot. Ltd. Sti.

Şahinbey, Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

favipiravir; Motion Pictures

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Aydin Erenmemisoglu
• Organization: Farmagen

a.erenmemisoglu@farmagenarge.com

+90 532 551 0082

Study Officials

• Muradiye Nacak, MD,PhD

  Farmagen Ar-Ge Biyot. Ltd. Sti

  PRINCIPAL INVESTIGATOR

• Taner Ezgi, MD

  Farmagen Ar-Ge Biyot. Ltd. Sti

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: May 28, 2020
• Primary Completion: June 5, 2020
• Study Completion: June 18, 2020
• Last Updated: August 11, 2020
• Results First Posted: August 11, 2020

Record last verified: 2020-08

Locations

TU (2)