- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04407000
Bioequivalence Study of Favipiravir 200 mg Film Tablet (World Medicine, Turkey) Under Fasting Conditions (Favipiravir)
August 8, 2020 updated by: World Medicine ILAC SAN. ve TIC. A.S.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Akyurt, Ankara, Turkey, 06970
- Novagenix Drug R&D Center
-
-
Gaziantep
-
Sahinbey, Gaziantep, Turkey, 27000
- Farmagen Ar-Ge Biyot. Ltd. Sti.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Drug
Loqular 200 mg Film Tablet containing 200 mg favipiravir (World Medicine İlaç-Turkey)
|
Test Drug
Other Names:
|
Active Comparator: Reference drug
Avigan 200 mg Film Tablet containing 200 mg favipiravir (Toyama Chemical Industry Co.Ltd./Japan)
|
Reference Drug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary PK End Points AUC0-tlast
Time Frame: 12 weeks
|
AUC0-tlast of favipiravir
|
12 weeks
|
Primary PK End Points Cmax
Time Frame: 13 weeks
|
Cmax of favipiravir
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary PK End Points AUC0-inf
Time Frame: 14 weeks
|
AUC0-inf of favipiravir
|
14 weeks
|
Secondary PK End Points tmax
Time Frame: 15 weeks
|
tmax of favipiravir
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Muradiye Nacak, MD,PhD, Farmagen Ar-Ge Biyot. Ltd. Sti
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2020
Primary Completion (Actual)
July 20, 2020
Study Completion (Actual)
August 8, 2020
Study Registration Dates
First Submitted
May 24, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
May 29, 2020
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 8, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOV2020/01925
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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