Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT02095704
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'one month', 'description': 'AUC:the area under the concentration-time curve'}, {'measure': 'Cmax', 'timeFrame': 'one month', 'description': 'Cmax: maximum plasma concentration'}, {'measure': 'Tmax', 'timeFrame': 'one month', 'description': 'Tmax: the time point of maximum plasma concentration'}, {'measure': 'MRT', 'timeFrame': 'one month', 'description': 'MRT: mean residence time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies']}, 'descriptionModule': {'briefSummary': 'Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an orally administered solid dosage form. The aim of this study was to evaluate the pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters, investigators trend to propose a method to estimate in vivo dissolution time and dissolution kinetics of solid dosage form.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sex: Male or female (limited to PK study)\n2. Healthy volunteers, age: 18-45（medical history, physical examination, vital signs, ECG and lab tests are qualified during screening）\n3. Body Mass Index（BMI）:19\\~24 or body weight is not less than 50Kg\n4. Non-pregnant women confirmed by pregnancy test\n5. Vital Signs: after 3 minutes supination, the following measurements criteria should be within ranges: body temperature (axillary temperature), 36.0\\~37.0 ℃; blood pressure, SBP 90\\~140mmHg（12.0\\~18.7kpa）and DBP 60\\~90mmHg（8.0\\~12.0kpa）; arterial pulse: 60\\~100 bpm\n6. Non-hypersensitivity to this product or its similar product\n7. Non-smoker, non-alcoholic\n8. Subject must be able to sign Inform Consent prior to participation into this study\n9. Subject must be able to communicate with investigator and comply with study protocol.\n\nExclusion Criteria:\n\nSubjects meet with one or several of the following criteria should be excluded:\n\n1. Subjects failed in physical examination\n2. Pregnant or nursing women\n3. Administration of a known drug that can cause damage to organs within 3 months\n4. Administration of any prescription drug or non-prescription drug 2 weeks before initial dose\n5. Before initial dose, participation in any other clinical trials within 3 months\n6. Blood donation 3 months before this study, or plan to have blood donation during or one month after this study\n7. Diagnosis of clinical evident diseases 2 weeks before initial dose\n8. Primary diseases to vital organs\n9. Physically or mentally disabled\n10. Medical history of specific allergy (asthma, measles, eczematous dermatitis), or known to allergic to similar (including excipients)\n11. Any other surgical or internal medicinal conditions that might cause damage to study subjects or will change the absorption, distribution, metabolism and elimination of investigational drug, including:\n\n * inflammatory intestinal syndrome, peptic ulcer, alimentary tract hemorrhage\n * a history of severe gastrointestinal tract operation, such as gastrectomy, gastrosmoty / jejunostomy or large bowel resection\n * a history of hepatic disease or laboratory examination findings such as ALT, AST, γ-GT or T-Bili showing clinically significant abnormalities to liver\n * a history of renal disease or laboratory examination findings such as creatinine, urea nitrogen, or albuminuria showing clinically significant abnormalities to kidney\n * urination disorder or dysuresia.\n12. A history of immunological deficiency disease, or HIV positive\n13. HBV or HCV positive\n14. Women undergone menstrual period during study\n15. Consumption of a significant amount of smoking or drinking, that is drinking more than 28 units of alcohol per week (1 unit: 285ml of beer, 25ml of liquor, or 1 glass of wine), or smoking more than 2 cigarettes\n16. Frequent use of sedatives, hypnotics, stabilizers or other addictive drugs\n17. Consumption of more than 8 cups of tea, coffee, and or caffeine beverages\n18. Unable to complete this study for any others reasons.\n19. Investigators.'}, 'identificationModule': {'nctId': 'NCT02095704', 'briefTitle': 'Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'orgStudyIdInfo': {'id': 'CSU-YXY-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'paracetamol oral solution', 'description': 'dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose', 'interventionNames': ['Drug: paracetamol oral solution']}, {'type': 'EXPERIMENTAL', 'label': 'paracetamol tablet', 'description': 'dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose', 'interventionNames': ['Drug: paracetamol tablet']}], 'interventions': [{'name': 'paracetamol oral solution', 'type': 'DRUG', 'description': 'dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose', 'armGroupLabels': ['paracetamol oral solution']}, {'name': 'paracetamol tablet', 'type': 'DRUG', 'description': 'dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose', 'armGroupLabels': ['paracetamol tablet']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute of Drug Metabolism and Pharmacokinetics,School of Pharmaceutical Sciences,Central South University', 'investigatorFullName': 'Feifan Xie', 'investigatorAffiliation': 'Central South University'}}}}