Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 11:15 AM
Study NCT ID:
NCT01155934
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2010-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-01', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability based on Cmax and AUC parameters', 'timeFrame': '1 Month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bioavailability', 'Crossover', 'Risperidone'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the single-dose relative bioavailability study of 1 mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fed conditions.', 'detailedDescription': "Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr Reddy's Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TAB) 1 mg Risperidone Orally Disintegrating Tablets in Healthy Adult Male Volunteers under Fed Conditions"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects were included in the study only if they met all of the following criteria:\n\n* Healthy non-smoking (for at least 3 months) adult male volunteers, 18-45 years of age;\n* Weighing at least 60 kg for males and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);\n* Medically healthy subjects with clinically normal laboratory profiles and ECGs;\n* Voluntarily consent to participate in the study.\n\nExclusion Criteria:\n\nSubjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:\n\n* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, or psychiatric disease.\n* In addition, history or presence of:\n* alcoholism or drug abuse within the past year;\n* hypersensitivity or idiosyncratic reaction to risperidone or benzodiazepines or other antipsychotic drugs;\n* seizures;\n* glaucoma or hypermetropia.\n* Positive results on Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Virus (HCV) Tests.\n* Subjects whose sitting blood pressure is less than 110/60 mm Hg at screening or 100/55 mm Hg before dosing.\n* Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing. Subjects whose PR interval is ≥ 190 msec at screening and prior to dosing.\n* Subjects whose aTe interval is \\> 450 msec at screening and prior to dosing.\n* Subjects with a body temperature ≥38°C before dosing.\n* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.\n* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.\n* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.\n* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days, or 1500 mL of blood in 180 days, 2500 mL of blood in 1 year.\n* Subjects who have participated in another clinical trial within 28 days prior to the first dose.'}, 'identificationModule': {'nctId': 'NCT01155934', 'briefTitle': "Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions", 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': "Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TABTM)1 mg Risperidone Orally Disintegrating Tablets in Healthy Adult Male Volunteers Under Fed Conditions", 'orgStudyIdInfo': {'id': 'AA21566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risperidone Orally Disintegrating', 'description': "Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited", 'interventionNames': ['Drug: Risperidone Orally Disintegrating Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Risperdal M-TAB', 'description': '(Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products', 'interventionNames': ['Drug: Risperidone Orally Disintegrating Tablets']}], 'interventions': [{'name': 'Risperidone Orally Disintegrating Tablets', 'type': 'DRUG', 'otherNames': ['(Risperdal M-TAB) tablets of Janssen Pharmaceutica Products'], 'description': "Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited", 'armGroupLabels': ['Risperdal M-TAB', 'Risperidone Orally Disintegrating']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Geatano Morelli, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MDS Pharma Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vice President, Research & Development', 'oldOrganization': "Dr. Reddy's Laboratories Limited"}}}}