BioequivalencePhase 1FavipiravirNCT04407000
Bioequivalence Study of Favipiravir 200 mg Film Tablet (World Medicine, Turkey) Under Fasting Conditions
A Phase 1 study testing Test: Favipiravir 200 mg (LOQULAR) and Reference: Favipiravir 200 mg (Avigan) in people with Bioequivalence, run by World Medicine ILAC SAN. ve TIC. A.S. at 2 sites in Turkey (Türkiye).
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?
- Test: Favipiravir 200 mg (LOQULAR) and Reference: Favipiravir 200 mg (Avigan)
- 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
- 23 Jun 2020to 8 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
About this study
Official title: Open-label,Randomised,Single Oral Dose,Two-period,Cross-over Trial to Assess to Bioequivalence of Loqular 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
- Test: Favipiravir 200 mg (LOQULAR), Reference: Favipiravir 200 mg (Avigan)
- Keywords
- COVID-19 drug treatment, Antiviral Agents, Favipiravir, Novagenix, Farmagen, World Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test: Favipiravir 200 mg (LOQULAR)Drug
Also called LOQULAR 200 MG FT
Test Drug
Reference: Favipiravir 200 mg (Avigan)Drug
Also called Avigan 200 mg Film Tablet
Reference Drug
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | Loqular 200 mg Film Tablet containing 200 mg favipiravir (World Medicine İlaç-Turkey) Receives: Drug: Test: Favipiravir 200 mg (LOQULAR) |
| Reference drug | Active comparator | Avigan 200 mg Film Tablet containing 200 mg favipiravir (Toyama Chemical Industry Co.Ltd./Japan) Receives: Drug: Reference: Favipiravir 200 mg (Avigan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK End Points AUC0-tlast
AUC0-tlast of favipiravir
Measured: 12 weeks
Primary PK End Points Cmax
Cmax of favipiravir
Measured: 13 weeks
Secondary outcomes (2)
Secondary PK End Points AUC0-inf
AUC0-inf of favipiravir
Measured: 14 weeks
Secondary PK End Points tmax
tmax of favipiravir
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start23 Jun 2020
- Primary completion20 Jul 2020
- Study completion8 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- World Medicine ILAC SAN. ve TIC. A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novagenix Bioanalytical Drug R&D Center, Farmagen Ar-Ge Biyot. Ltd. Sti
- Responsible party
- Sponsor
- Investigators
- Muradiye Nacak, MD,PhD, Principal investigator, Farmagen Ar-Ge Biyot. Ltd. Sti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407000
- Sponsor's protocol ID
- NOV2020/01925
- Acronym
- Favipiravir
- Status last verified
- Aug 2020
- First submitted
- 24 May 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label,Randomised,Single Oral Dose,Two-period,Cross-over Trial to Assess to Bioequivalence of Loqular 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04407000
- Acronym / sponsor ID
- Favipiravir / NOV2020/01925
- Conditions
- Bioequivalence
- Keywords
- COVID-19 drug treatment, Antiviral Agents, Favipiravir, Novagenix, Farmagen, World Medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- World Medicine ILAC SAN. ve TIC. A.S.Industry (pharma, biotech, devices)
- Collaborators
- Novagenix Bioanalytical Drug R&D Center, Farmagen Ar-Ge Biyot. Ltd. Sti
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 8 Aug 2020 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: Test: Favipiravir 200 mg (LOQULAR)Loqular 200 mg Film Tablet containing 200 mg favipiravir (World Medicine İlaç-Turkey) |
| Reference drug | Active comparator | Drug: Reference: Favipiravir 200 mg (Avigan)Avigan 200 mg Film Tablet containing 200 mg favipiravir (Toyama Chemical Industry Co.Ltd./Japan) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test: Favipiravir 200 mg (LOQULAR)Also: LOQULAR 200 MG FTTest Drug | Drug | Test Drug |
| Reference: Favipiravir 200 mg (Avigan)Also: Avigan 200 mg Film TabletReference Drug | Drug | Reference drug |
Primary outcome
Primary PK End Points AUC0-tlast
Time frame: 12 weeks
AUC0-tlast of favipiravir
Primary PK End Points Cmax
Time frame: 13 weeks
Cmax of favipiravir
2 secondary outcomes
Secondary PK End Points AUC0-inf
Time frame: 14 weeks
Secondary PK End Points tmax
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muradiye Nacak, MD,PhD principal investigator
Farmagen Ar-Ge Biyot. Ltd. Sti
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test: Favipiravir 200 mg (LOQULAR) and Reference: Favipiravir 200 mg (Avigan) in people with Bioequivalence, run by World Medicine ILAC SAN. ve TIC. A.S. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary PK End Points AUC0-tlast (time frame: 12 weeks). 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?
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.