Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers

Study Overview
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Brief Summary
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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.

Conditions
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Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies

Intervention / Treatment
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* Drug: paracetamol oral solution
* Drug: paracetamol tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paracetamol oral solution<br>dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose | Drug: paracetamol oral solution<br>* dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose<br>|
| Experimental: paracetamol tablet<br>dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose | Drug: paracetamol tablet<br>* dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | AUC:the area under the concentration-time curve | one month | 
| Cmax | Cmax: maximum plasma concentration | one month | 
| Tmax | Tmax: the time point of maximum plasma concentration | one month | 
| MRT | MRT: mean residence time | one month |