Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-11 @ 4:37 PM
Study NCT ID:
NCT04406194
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2020-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
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1.25 equivalence margin is required.'}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post-dose', 'description': 'Maximum plasma concentration of favipiravir', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '29 subjects were analysed and included in statistical analysis.'}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Favipiravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favicovir 200 mg FT', 'description': 'Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.'}, {'id': 'OG001', 'title': 'Avigan 200 mg FT', 'description': 'Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '9910.494', 'spread': '2618.9', 'groupId': 'OG000'}, {'value': '10152.115', 'spread': '2507.694', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9719', 'ciLowerLimit': '0.9440', 'ciUpperLimit': '1.0006', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.80 - 1.25 equivalence margin is not required.'}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post-dose', 'description': 'Area under the plasma concentration curve to infinite time of favipiravir', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '29 subjects were analysed and included in statistical analysis.'}, {'type': 'SECONDARY', 'title': 'Tmax of Favipiravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favicovir 200 mg FT', 'description': 'Participants received single dose of 200 mg Favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.'}, {'id': 'OG001', 'title': 'Avigan 200 mg FT', 'description': 'Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.609', 'spread': '0.343', 'groupId': 'OG000'}, {'value': '0.733', 'spread': '0.478', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post-dose', 'description': 'Time to reach maximum plasma concentration of favipiravir', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '29 subjects were analysed and included in statistical analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: FAVICOVIR Then AVIGAN', 'description': '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.'}, {'id': 'FG001', 'title': 'AVIGAN Then FAVICOVIR', 'description': '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.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '57 subject screened'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FAVICOVIR Then AVIGAN', 'description': '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.'}, {'id': 'BG001', 'title': 'AVIGAN Then FAVICOVIR', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'subjects'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-28', 'size': 1248233, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-10T04:18', 'hasProtocol': True}, {'date': '2020-04-28', 'size': 560198, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-10T04:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2020-05-24', 'resultsFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-tlast of Favipiravir', 'timeFrame': '0 to 24 hours post-dose', 'description': 'Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours'}, {'measure': 'Cmax of Favipiravir', 'timeFrame': '0 to 24 hours post-dose', 'description': 'Maximum plasma concentration of favipiravir'}], 'secondaryOutcomes': [{'measure': 'AUC0-inf of Favipiravir', 'timeFrame': '0 to 24 hours post-dose', 'description': 'Area under the plasma concentration curve to infinite time of favipiravir'}, {'measure': 'Tmax of Favipiravir', 'timeFrame': '0 to 24 hours post-dose', 'description': 'Time to reach maximum plasma concentration of favipiravir'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 drug treatment', 'Antiviral Agents', 'Favipiravir', 'Novagenix', 'Farmagen'], 'conditions': ['Bioequivalence']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy Caucasian male subjects aged between 20 and 40 years\n2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period\n3. Two Negative Covid-19 PCR test results\n4. Negative alcohol breath test results\n5. Normal physical examination at screening visit\n6. 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\n7. Ability to communicate adequately with the investigator himself or his representatives\n8. Ability and agreement to comply with the study requirements\n9. 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\n10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest\n11. 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)\n12. Understanding of the study and agreement to give a written informed consent according to section 20.3\n13. Understanding of that he and his partner will use a practice adequate contraception during the study and at least 7 days after the study\n14. Volunteer's compliance with isolation rules defined at study protocol\n\nExclusion Criteria:\n\n1. Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products.\n2. 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.\n3. 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),\n4. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.\n5. 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.\n6. 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.\n7. 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).\n8. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.\n9. History of allergic response to heparin.\n10. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.\n11. 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.\n12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study.\n13. History of drug abuse.\n14. 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).\n15. Positive blood test for HBV, HCV and HIV.\n16. Who have relationship to the investigator.\n17. Who are not suitable to any of inclusion criteria.\n18. History of difficulty of swallowing.\n19. Intake of depot injectable solutions (including study medications) within 6 months before start of the study.\n20. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study.\n21. Special diet due to any reason, e.g. vegetarian."}, 'identificationModule': {'nctId': 'NCT04406194', 'acronym': 'Favipiravir', 'briefTitle': 'Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atabay Kimya Sanayi Ticaret A.S.'}, 'officialTitle': 'Open-label,Randomised,Single Oral Dose,Two-period,Cross-over Trial to Assess to Bioequivalence of Favicovir 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'NOV2020/1917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAVICOVIR then AVIGAN', 'description': '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.', 'interventionNames': ['Drug: FAVICOVIR 200 mg Film Tablet', 'Drug: AVIGAN 200 mg Film Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'AVIGAN then FAVICOVIR', 'description': '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.', 'interventionNames': ['Drug: FAVICOVIR 200 mg Film Tablet', 'Drug: AVIGAN 200 mg Film Tablets']}], 'interventions': [{'name': 'FAVICOVIR 200 mg Film Tablet', 'type': 'DRUG', 'otherNames': ['Favipiravir 200 MG FT'], 'description': 'FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.', 'armGroupLabels': ['AVIGAN then FAVICOVIR', 'FAVICOVIR then AVIGAN']}, {'name': 'AVIGAN 200 mg Film Tablets', 'type': 'DRUG', 'otherNames': ['Favipiravir 200 mg FT'], 'description': 'AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.', 'armGroupLabels': ['AVIGAN then FAVICOVIR', 'FAVICOVIR then AVIGAN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06970', 'city': 'Akyurt', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novagenix Drug R&D Center', 'geoPoint': {'lat': 40.13512, 'lon': 33.08614}}, {'zip': '27000', 'city': 'Şahinbey', 'state': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Farmagen Ar-Ge Biyot. Ltd. Sti.', 'geoPoint': {'lat': 36.907, 'lon': 37.20414}}], 'overallOfficials': [{'name': 'Muradiye Nacak, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Farmagen Ar-Ge Biyot. Ltd. Sti'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atabay Kimya Sanayi Ticaret A.S.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novagenix Bioanalytical Drug R&D Center', 'class': 'NETWORK'}, {'name': 'Farmagen Ar-Ge Biyot. Ltd. Sti', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}