Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-05 @ 8:23 AM
Study NCT ID:
NCT04039958
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Partial replicate crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal measured plasma concentration (Cmax)', 'timeFrame': 'Up to 72 hours post dose in each treatment period', 'description': 'Serial blood samples for determination of study drug will be collected at 0.00, 0.166, 0.33, 0.50, 0.75, 1.00, 1.33, 1.66, 2.00, 2.50, 3.00, 4.00, 6.00, 7.00 , 9.00, 12.00, 24.00, 48.00 and 72.00 hours'}], 'secondaryOutcomes': [{'measure': 'Time of the maximum plasma concentration (Tmax)', 'timeFrame': 'Up to 72 hours post dose in each treatment period', 'description': 'The amount of time that a drug is present at the maximum concentration in serum'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '11381568', 'type': 'BACKGROUND', 'citation': 'Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.'}, {'pmid': '2004861', 'type': 'BACKGROUND', 'citation': 'Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.'}, {'pmid': '3450848', 'type': 'BACKGROUND', 'citation': 'Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.'}]}, 'descriptionModule': {'briefSummary': 'Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA) in Healthy Human Volunteers Under Fasting Condition.', 'detailedDescription': 'Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.\n\nA comprehensive final report will be issued upon the completion of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male or female, age 18 to 55 years, inclusive.\n2. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).\n3. Medical demographics without evidence of clinically significant deviation from normal medical condition.\n4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.\n5. Subject does not have allergy to the drugs under investigation.\n\nExclusion Criteria:\n\n1. Subjects with known allergy to the products tested.\n2. Subjects whose values of BMI were outside the accepted normal ranges.\n3. Female subjects who were pregnant, nursing or taking birth control pills.\n4. Medical demographics with evidence of clinically significant deviation from normal medical condition.\n5. Results of laboratory tests which are clinically significant.\n6. Acute infection within one week preceding first study drug administration.\n7. History of drug or alcohol abuse.\n8. Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.\n9. Subject is on a special diet (for example subject is vegetarian).\n10. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.\n11. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.\n12. Subject has a history of severe diseases which have direct impact on the study.\n13. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.\n14. Subject intends to be hospitalized within 3 months after first study drug administration.\n15. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.'}, 'identificationModule': {'nctId': 'NCT04039958', 'briefTitle': 'A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genuine Research Center, Egypt'}, 'officialTitle': 'Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)', 'orgStudyIdInfo': {'id': 'GRC/1/17/635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T test', 'description': 'Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir', 'interventionNames': ['Drug: Soviredia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B reference (first dose)', 'description': 'Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir', 'interventionNames': ['Drug: Harvoni (first dose)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B reference (second dose)', 'description': 'Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir', 'interventionNames': ['Drug: Harvoni (Second dose)']}], 'interventions': [{'name': 'Soviredia', 'type': 'DRUG', 'otherNames': ['Harvoni'], 'description': 'Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir', 'armGroupLabels': ['T test']}, {'name': 'Harvoni (first dose)', 'type': 'DRUG', 'otherNames': ['Harvoni'], 'description': 'Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir', 'armGroupLabels': ['B reference (first dose)']}, {'name': 'Harvoni (Second dose)', 'type': 'DRUG', 'otherNames': ['Harvoni'], 'description': 'Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir', 'armGroupLabels': ['B reference (second dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11757', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Genuine Research Center GRC', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Elshafeey, Ph.D. Pharma', 'role': 'STUDY_CHAIR', 'affiliation': 'Genuine Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genuine Research Center, Egypt', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MinaPharm Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}