Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 1:14 AM
Study NCT ID:
NCT01161966
Status:
COMPLETED
Last Update Posted:
2010-07-14
First Post:
2010-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078305', 'term': 'Zonisamide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-01', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-13', 'studyFirstSubmitDate': '2010-07-13', 'studyFirstSubmitQcDate': '2010-07-13', 'lastUpdatePostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence on Cmax,AUC and Tmax Parameters', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in fasted subjects.", 'detailedDescription': 'This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fasting conditions. Subjects were confined to the SFBC Clinical Research Facility from at least 10 hours prior to drug administration, until after the 24-hour post-dose blood draw, in each period. The treatment phases were separated by a washout period of 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate?\n* Is s/he at least 18 years of age?\n* Is his/her BMI between 19 and 30, inclusive?\n* Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?\n* Has s/he provided written informed consent?\n\nExclusion Criteria:\n\n* Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides?\n* Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?\n* Does s/he have serious psychological illness?\n* Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?\n* Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test?\n* Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?\n* Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken?\n* Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?\n* Is s/he unable to refrain from the use of all concomitant medications during the study?\n* Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?\n* Has s/he donated plasma during the two week period preceding study initiation?\n* Has s/he received an investigational drug during the 30 day Period preceding study initiation?'}, 'identificationModule': {'nctId': 'NCT01161966', 'briefTitle': "Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions", 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'A Randomized. Single-Dose, Two-Way Crossover Relative Bioavailability Study of Zonisamide Formulations in Fasted Normal, Healthy Men and Women', 'orgStudyIdInfo': {'id': '40577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zonisamide', 'description': "Zonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited", 'interventionNames': ['Drug: Zonisamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zonegran', 'description': 'Zonegran Capsules 100 mg of EISAI INC', 'interventionNames': ['Drug: Zonegran']}], 'interventions': [{'name': 'Zonisamide', 'type': 'DRUG', 'otherNames': ['Zonegran Capsules 100 mg'], 'description': 'Zonisamide capsules 100 mg', 'armGroupLabels': ['Zonisamide']}, {'name': 'Zonegran', 'type': 'DRUG', 'description': 'Zonegran Capsules 100 mg of EISAI INC', 'armGroupLabels': ['Zonegran']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'SFBC Ft. Myers, Inc.', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}], 'overallOfficials': [{'name': 'Antonio R Pizarro, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SFBC Ft. Myers, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vice president-Research & Development', 'oldOrganization': "Dr. Reddy's Laboratories Limited"}}}}