Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 11:38 AM
Study NCT ID:
NCT00973232
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2009-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007863', 'term': 'Lecithin Cholesterol Acyltransferase Deficiency'}], 'ancestors': [{'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D014147', 'term': 'Tramadol'}, {'id': 'C478659', 'term': 'Ultracet'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-24', 'studyFirstSubmitDate': '2009-09-08', 'studyFirstSubmitQcDate': '2009-09-08', 'lastUpdatePostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate and extent of exposure', 'timeFrame': '0 to 36 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tramadol', 'Acetaminophen', 'combination', 'pharmacokinetics', 'bioavailability', 'Zaldiar', 'Ultracet', 'fed', 'fasted', 'single-dose', 'multiple-dose', 'healthy', 'volunteers', 'Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation.', 'detailedDescription': '* To compare the single (Part A) and multiple dose (Part B) pharmacokinetic profiles and bioavailability of DDS-06C tablets with the immediate-release tablet reference products Zaldiar® and Ultracet®.\n* To assess the effect of food on the pharmacokinetic profile of DDS-06C tablets following administration of a single oral dose.\n* To monitor and record all adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males or females aged 18-55 years inclusive with body mass index (BMI) between 18-30 kg/m2\n* Healthy as determined by pre-study medical history, physical examination and 12-lead ECG\n* Clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator\n* Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening\n* Negative for drugs of abuse and alcohol at screening and admission\n* Non-smokers for at least 3 months preceding screening\n* If female, were not currently pregnant or breast feeding and were using medically acceptable methods of contraception and if male, were themselves and their female partners using medically acceptable methods of contraception\n* Able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* Subjects who did not conform to the above inclusion criteria\n* Female subjects who were pregnant, trying to become pregnant, lactating or not using acceptable methods of contraception\n* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders\n* Clinically relevant surgical history\n* Clinically relevant family history\n* History of relevant atopy\n* History of relevant drug hypersensitivity\n* History of alcoholism\n* History of drug abuse\n* Male subjects who consumed more than 21 units of alcohol a week and female subjects who consumed more than 14 units of alcohol a week\n* Significant infection or known inflammatory process on screening\n* Acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)\n* Acute infection such as influenza at the time of screening or admission\n* Use of prescription drugs within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor\n* Use of over-the-counter medication excluding routine vitamins but including mega dose vitamin therapy within 14 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor\n* Use of any investigational drug or participation in any clinical trial within 3 months of their first dosing\n* Donation or receipt of any blood or blood products within the previous 3 months prior to first dosing\n* Vegetarians, vegans or having medical or cultural dietary restrictions.\n* Inability to communicate reliably with the Investigator.\n* Subjects who were unlikely to co-operate with the requirements of the study'}, 'identificationModule': {'nctId': 'NCT00973232', 'briefTitle': 'A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Labopharm Inc.'}, 'officialTitle': 'A Single-Centre, Open-Label, Randomised Study to Compare the Single Dose (Including the Effect of Food) and Multiple Dose Pharmacokinetic Profiles of Acetram Contramid® BID Tablets vs the Immediate-Release Tablet Reference Products Zaldiar® and Ultracet®', 'orgStudyIdInfo': {'id': '06CCL102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Arm A', 'interventionNames': ['Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl)']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Arm B', 'interventionNames': ['Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part A, Arm C', 'interventionNames': ['Drug: Zaldiar®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part A, Arm D', 'interventionNames': ['Drug: Ultracet®']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Arm E', 'interventionNames': ['Drug: Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B, Arm F', 'interventionNames': ['Drug: Zaldiar®, multiple doses,(fed & fasting):']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B, Arm G', 'interventionNames': ['Drug: Ultracet®, multiple doses, (fed & fasting)']}], 'interventions': [{'name': 'DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl)', 'type': 'DRUG', 'description': 'DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fasting conditions', 'armGroupLabels': ['Part A, Arm A']}, {'name': 'DDS-06C (650 mg acetaminophen and 75 mg tramadol)', 'type': 'DRUG', 'description': 'DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fed conditions', 'armGroupLabels': ['Part A, Arm B']}, {'name': 'Zaldiar®', 'type': 'DRUG', 'description': 'Zaldiar® (325 mg acetaminophen and 37.5 mg tramadol HCl): two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)', 'armGroupLabels': ['Part A, Arm C']}, {'name': 'Ultracet®', 'type': 'DRUG', 'description': 'Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)', 'armGroupLabels': ['Part A, Arm D']}, {'name': 'Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions', 'type': 'DRUG', 'description': 'Two tablets of DDS-06C, twice daily at 12-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl', 'armGroupLabels': ['Part B, Arm E']}, {'name': 'Zaldiar®, multiple doses,(fed & fasting):', 'type': 'DRUG', 'description': 'Two tablets of Zaldiar®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl', 'armGroupLabels': ['Part B, Arm F']}, {'name': 'Ultracet®, multiple doses, (fed & fasting)', 'type': 'DRUG', 'description': 'Two tablets of Ultracet®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl', 'armGroupLabels': ['Part B, Arm G']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 1YR', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Drug Research Unit, Quintiles Ltd", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Darren Wilbraham', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's Drug Research Unit, Quintiles Ltd"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Labopharm Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}