Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 7:09 PM
Study NCT ID:
NCT01552850
Status:
COMPLETED
Last Update Posted:
2015-08-31
First Post:
2012-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-28', 'studyFirstSubmitDate': '2012-03-09', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit.', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose'}, {'measure': 'Plasma Decay Half-Life of oxycodone, as data permit.', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose'}, {'measure': 'Concentration at time 24 hours (C24) of oxycodone, as data permit.', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose'}, {'measure': 'Adverse events, vital signs and laboratory parameters.', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'relative bioavailability', 'oxycodone'], 'conditions': ['Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4501010&StudyName=Pharmacokinetics%20And%20Relative%20Bioavailability%20Study%20Of%20Oxycodone%0A', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution', 'detailedDescription': 'This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant diseases'}, 'identificationModule': {'nctId': 'NCT01552850', 'briefTitle': 'Pharmacokinetics And Relative Bioavailability Study Of Oxycodone', 'organization': {'class': 'UNKNOWN', 'fullName': 'PainT'}, 'officialTitle': 'An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B4501010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxycodone Formulation A Capsule', 'description': 'single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone Formulation B Capsule', 'description': 'single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone Formulation C Capsule', 'description': 'single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone Formulation D Capsule', 'description': 'single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone Oral Solution', 'description': '40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block', 'interventionNames': ['Drug: Oxycodone']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'description': '1X40 mg PF-00345439 formulation A capsule with water and under fed condition', 'armGroupLabels': ['Oxycodone Formulation A Capsule']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': '1X40 mg PF-00345439 formulation B capsule with water and under fed condition', 'armGroupLabels': ['Oxycodone Formulation B Capsule']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': '1X40 mg PF-00345439 formulation C capsule with water and under fed condition', 'armGroupLabels': ['Oxycodone Formulation C Capsule']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': '1X40 mg PF-00345439 formulation D capsule with water and under fed condition', 'armGroupLabels': ['Oxycodone Formulation D Capsule']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': '40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition', 'armGroupLabels': ['Oxycodone Oral Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pain Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}