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BioequivalencePhase 1FavipiravirNCT04400682

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

A Phase 1 study testing FAVIRA 200 MG Film Tablet and AVIGAN 200 MG Film Tablets in people with Bioequivalence, run by Novelfarma Ilaç San. ve Tic. Ltd. Sti. at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
FAVIRA 200 MG Film Tablet and AVIGAN 200 MG Film Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesTurkey (Türkiye)
Study dates
28 May 2020to 18 Jun 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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.
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  • 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).
  • Positive blood test for HBV, HCV and HIV.
  • Who have relationship to the investigator.
  • Who are not suitable to any of inclusion criteria.
  • History of difficulty of swallowing.
  • Intake of depot injectable solutions (including study medications) within 6 months before start of the study.
  • Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.
  • Special diet due to any reason, e.g. vegetarian.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Novagenix Drug R&D Center

    Akyurt, Ankara, 06970

  • Farmagen Ar-Ge Biyot. Ltd. Sti.

    Şahinbey, Gaziantep, 27000

Other trials in Turkey (Türkiye)

About this study

Official title: Open-label, Randomised, Single Oral Dose, Two-period, Cross-over Trial to Assess to Bioequivalence of Favira 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions

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.

Read the 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
Being tested
FAVIRA 200 MG Film Tablet, AVIGAN 200 MG Film Tablets
Keywords
COVID-19 drug treatment, Antiviral Agents, Favipiravir, Novagenix, Farmagen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAVIRA 200 MG Film TabletDrug

    Also called FAVIRA 200 MG FT

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

  • AVIGAN 200 MG Film TabletsDrug

    Also called AVIGAN 200 mg FT

    AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan

Study groups in NCT04400682
Study groupRoleWhat they receive
FAVIRA then AVIGANExperimentalParticipants 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.
Receives: Drug: FAVIRA 200 MG Film Tablet; Drug: AVIGAN 200 MG Film Tablets
AVIGAN then FAVIRAExperimentalParticipants 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.
Receives: Drug: FAVIRA 200 MG Film Tablet; Drug: AVIGAN 200 MG Film Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-tlast

    AUC0-tlast of favipiravir will be obtained from plasma concentrations

    Measured: 0 to 24 hours post dose

  2. Favipiravir Cmax

    Favipiravir Cmax Cmax of favipiravir will be obtained from plasma concentrations

    Measured: 0 to 24 hours post dose

Secondary outcomes (2)

  1. AUC0-inf of Favipiravir

    AUC0-inf of favipiravir will be obtained from plasma concentrations

    Measured: 0 to 24 hours post dose

  2. Tmax of Favipiravir

    tmax of favipiravir will be obtained from plasma concentrations

    Measured: 0 to 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start28 May 2020
  3. Primary completion5 Jun 2020
  4. Study completion18 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400682
Sponsor's protocol ID
NOV2020/1923
Other IDs
FARGE 367
Acronym
Favipiravir
Status last verified
Aug 2020
First submitted
19 May 2020
Last updated
11 Aug 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FAVIRA 200 MG Film Tablet and AVIGAN 200 MG Film Tablets in people with Bioequivalence, run by Novelfarma Ilaç San. ve Tic. Ltd. Sti. at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-tlast (time frame: 0 to 24 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04400682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.

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