Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

Inclusion criteria

• Male and non-pregnant female, 18 to 55 years of age
• Body Mass Index (BMI) between 18 to 25 kg/m2
• Accessible vein for blood sampling
• High probability for compliance and completion of the study
• Female subjects who are surgically sterile or post-menopausal. Or female subjects of child bearing potential agree to practice abstinence or take effective contraceptive methods (e.g.implanted contraceptives, intra-uterine device or consistent condom plus spermicide use) from the start of screening until two weeks of last dose administration to prevent pregnancy.
• Have signed the written informed consent to participate in the study.

Exclusion criteria

• Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic and other diseases
• Clinically significant abnormality in physical examination, vital signs, laboratory test results and ECG evaluation
• Positive results of hepatitis B
• Moderate smoker (more than 2 cigarettes a day within 3 months prior to the start of first dosing)
• Moderate consumption of alcohol (more than one drink per day within 3 months prior to the start of first dosing)
• Have lost or donated more than 350 ml of blood within 3 months prior to the start of first dosing
• Subjects who are taking prescription or non-prescription medications (except for contraceptives, refer to "Inclusion Criteria" section) which is likely to be required during the course of the study
• Use of paracetamol or other analgesic/antipyretic medications within 4 weeks before first dosing
• Volunteer in any other clinical drug study within 2 months prior to the start of first dosing
• Hypersensitivity to paracetamol or other drugs in its class
• History of drug abuse in any form
• Female subjects who are breastfeeding or pregnant
• Subjects who are considered not suitable in participating the study due to other factors judged by investigators