Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-04 @ 3:40 PM
Study NCT ID:
NCT05135793
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2021-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-14', 'studyFirstSubmitDate': '2021-11-14', 'studyFirstSubmitQcDate': '2021-11-14', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'up to 48 hours post dose in each treatment period', 'description': 'Maximal measured plasma concentration'}], 'secondaryOutcomes': [{'measure': 'Time of the maximum plasma concentration (Tmax)', 'timeFrame': 'Up to 48 hours post dose in each treatment period', 'description': 'The amount of time that a drug is present at the maximum concentration in serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, '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': 'An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)', 'detailedDescription': 'Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. All dosed subject samples will be analyzed and their data will be included in the final study report.\n\nPrimary Pharmacokinetic Parameters: Cmax, 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.\n\nThe 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, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.\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. Females should be on a suitable birth control method.\n6. Fully informed subjects that consented to participate in the study.\n\nExclusion Criteria:\n\n1. Subjects with known allergy to the products tested.\n2. Female subjects who were pregnant or nursing.\n3. Acute infection within one week preceding first study drug administration.\n4. History of drug or alcohol abuse.\n5. Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.\n6. Subject is on a special diet (for example subject is vegetarian).\n7. 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.\n8. 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.\n9. Subject has a family history of severe diseases which have direct impact on the study.\n10. Participation in a bioequivalence study or in a clinical study within the last 8 weeks before first study drug administration.\n11. Subject intends to be hospitalized within 3 months after first study drug administration.\n12. Subjects who has blood donated or lost more than 500 mL blood within 3 months prior to the study.'}, 'identificationModule': {'nctId': 'NCT05135793', 'briefTitle': 'Bioequivalence Study of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genuine Research Center, Egypt'}, 'officialTitle': 'An Open Label Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan) in Healthy Human Volunteers Under Fasting Condition', 'orgStudyIdInfo': {'id': 'GRC/1/20/896'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A test', 'description': 'Test drug (Topoprazan) 1 tablet contains 20 mg vonoprazan', 'interventionNames': ['Drug: Topoprazan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B reference', 'description': 'Reference drug (Takecab) 1 tablets contains 20 mg vonoprazan', 'interventionNames': ['Drug: Takecab']}], 'interventions': [{'name': 'Topoprazan', 'type': 'DRUG', 'otherNames': ['Takecab'], 'description': '1 tablet contains 20 mg vonoprazan', 'armGroupLabels': ['A test']}, {'name': 'Takecab', 'type': 'DRUG', 'description': '1 tablet contains 20 mg vonoprazan', 'armGroupLabels': ['B reference']}]}, '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_DIRECTOR', 'affiliation': 'Genuine Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genuine Research Center, Egypt', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hikma Pharma', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}