Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 3:12 AM
Study NCT ID:
NCT01506050
Status:
COMPLETED
Last Update Posted:
2012-01-09
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C121345', 'term': 'desloratadine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-06', 'studyFirstSubmitDate': '2012-01-05', 'studyFirstSubmitQcDate': '2012-01-06', 'lastUpdatePostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under curve(AUC)', 'timeFrame': 'Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120 and 144 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Desloratadine', 'crossover'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.', 'detailedDescription': "The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine ODT 5 mg and Schering Corporation, U.S.A.(Clarinex® 5 mg), desloratadine ODT 5 mg under fasting conditions. The treatment phases were separated by a washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 35 of these enrolled subjects completed the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is the individual a healthy, normal adult man or woman who volunteers to participate?\n* Is s/he within 18 to 45 years of age, inclusive?\n* Is his/her BMI between 19 and 30 inclusive?\n* Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study?\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 or allergy or hypersensitivity to desloratadine?\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?\n* Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?\n* Is she nursing?\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-I, or hepatitis B or C screen, or a positive pregnancy test?\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 in each study period?\n* Has s/he used any prescription drug, other than hormonal contraceptives, 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, other than hormonal contraceptives, 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 initiated?\n* Has s/he used any tobacco products in the 3 months preceding drug administration?'}, 'identificationModule': {'nctId': 'NCT01506050', 'briefTitle': 'Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'Randomized, Single Dose, 2-Way Crossover, Relative Bioavailability Study of Desloratadine Orally Disintegrating Tablet Fasting Conditions', 'orgStudyIdInfo': {'id': '50632'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desloratadine OD tablets 5 mg', 'description': "Desloratadine OD tablets 5 mg of Dr. Reddy's Laboratories Limited", 'interventionNames': ['Drug: Desloratadine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clarinex', 'description': 'Clarinex 5 mg of Schering Corporation Inc USA', 'interventionNames': ['Drug: Desloratadine']}], 'interventions': [{'name': 'Desloratadine', 'type': 'DRUG', 'otherNames': ['Clarinex ODT 5 mg'], 'description': 'Desloratadine ODT 5 mg', 'armGroupLabels': ['Clarinex', 'Desloratadine OD tablets 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Broadway', 'state': 'Florida', 'country': 'United States', 'facility': 'SFBC Ft Myers Inc', 'geoPoint': {'lat': 27.9643, 'lon': -82.3874}}], 'overallOfficials': [{'name': 'Antonio R Pizarro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SFBC Anapharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}