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

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.