- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02095704
Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers
March 24, 2014 updated by: Feifan Xie, Central South University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Sex: Male or female (limited to PK study)
- Healthy volunteers, age: 18-45(medical history, physical examination, vital signs, ECG and lab tests are qualified during screening)
- Body Mass Index(BMI):19~24 or body weight is not less than 50Kg
- Non-pregnant women confirmed by pregnancy test
- 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
- Non-hypersensitivity to this product or its similar product
- Non-smoker, non-alcoholic
- Subject must be able to sign Inform Consent prior to participation into this study
- Subject must be able to communicate with investigator and comply with study protocol.
Exclusion Criteria:
Subjects meet with one or several of the following criteria should be excluded:
- Subjects failed in physical examination
- Pregnant or nursing women
- Administration of a known drug that can cause damage to organs within 3 months
- Administration of any prescription drug or non-prescription drug 2 weeks before initial dose
- Before initial dose, participation in any other clinical trials within 3 months
- Blood donation 3 months before this study, or plan to have blood donation during or one month after this study
- Diagnosis of clinical evident diseases 2 weeks before initial dose
- Primary diseases to vital organs
- Physically or mentally disabled
- Medical history of specific allergy (asthma, measles, eczematous dermatitis), or known to allergic to similar (including excipients)
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:
- inflammatory intestinal syndrome, peptic ulcer, alimentary tract hemorrhage
- a history of severe gastrointestinal tract operation, such as gastrectomy, gastrosmoty / jejunostomy or large bowel resection
- a history of hepatic disease or laboratory examination findings such as ALT, AST, γ-GT or T-Bili showing clinically significant abnormalities to liver
- a history of renal disease or laboratory examination findings such as creatinine, urea nitrogen, or albuminuria showing clinically significant abnormalities to kidney
- urination disorder or dysuresia.
- A history of immunological deficiency disease, or HIV positive
- HBV or HCV positive
- Women undergone menstrual period during study
- 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
- Frequent use of sedatives, hypnotics, stabilizers or other addictive drugs
- Consumption of more than 8 cups of tea, coffee, and or caffeine beverages
- Unable to complete this study for any others reasons.
- Investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: paracetamol oral solution
dosage form: paracetamol oral solution;dosage:15.6ml(containing
500 mg of the active ingredient);frequency:single dose
|
dosage form: paracetamol oral solution;dosage:15.6ml(containing
500 mg of the active ingredient);frequency:single dose
|
Experimental: paracetamol tablet
dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
|
dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC
Time Frame: one month
|
AUC:the area under the concentration-time curve
|
one month
|
Cmax
Time Frame: one month
|
Cmax: maximum plasma concentration
|
one month
|
Tmax
Time Frame: one month
|
Tmax: the time point of maximum plasma concentration
|
one month
|
MRT
Time Frame: one month
|
MRT: mean residence time
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 19, 2014
First Submitted That Met QC Criteria
March 24, 2014
First Posted (Estimate)
March 26, 2014
Study Record Updates
Last Update Posted (Estimate)
March 26, 2014
Last Update Submitted That Met QC Criteria
March 24, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSU-YXY-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies
-
Sindhu R Kaitha, MDCompletedPrimary Focus of the Study is Cost-minimization AnalysisUnited States
-
Lipscomb UniversityDeerland EnzymesCompletedFocus of Study is Amino Acid Appearace in BloodUnited States
-
State University of New York - Upstate Medical...WithdrawnAssess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.)United States
-
Ziv HospitalUnknownFocus of the Study Includes Patients in PainIsrael
-
Albert Einstein Healthcare NetworkRobert Wood Johnson FoundationCompletedFocus of the Study is on the Use of Incentives to Promote | Healthier Eating in Low-income CommunitiesUnited States
-
Cairo UniversityNot yet recruitingthe Main Focus of the Study is to Use Socket Sealing Abutment in Conditioning of the Soft Tissue After Immediate Implant Placement
-
London School of Hygiene and Tropical MedicineUniversity of Colorado, Boulder; Ministry of Health, Rwanda; Portland State University and other collaboratorsCompletedFocus of Study is to Assess Filter and Stove Use and Efficacy in Reducing Exposure to Waterborne and Airborne PathogensRwanda
-
Heba A YassaEnrolling by invitationthe Study Focus on the Uses of Telephone and Other New Technology in Medicine, Diagnosis and TreatmentEgypt
-
Jinnah Sindh Medical UniversityAl Khidmat Hospital Nazimabad Karachi; Medics Laboratories (Pvt.) Ltd.CompletedThe Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive PatientsPakistan
-
European Institute for Evidence Based Osteopathic...AvailableThe Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.
Clinical Trials on paracetamol oral solution
-
Milton S. Hershey Medical CenterTerminatedStroke | Subarachnoid HemorrhageUnited States
-
Baxter Healthcare CorporationCompletedPain, PostoperativeUnited Kingdom
-
Foresee Pharmaceuticals Co., Ltd.CompletedHealthy VolunteersAustralia
-
Crinetics Pharmaceuticals Inc.CompletedHealthy VolunteersAustralia
-
AlzProtect SASActive, not recruitingProgressive Supranuclear PalsyFrance
-
Crinetics Pharmaceuticals Inc.CompletedHealthy VolunteersUnited States
-
Baxter Healthcare CorporationMDS Pharma ServicesCompleted
-
Emergent BioSolutionsNational Institute of Allergy and Infectious Diseases (NIAID)TerminatedViral InfectionUnited States
-
IRCCS Burlo GarofoloCompleted