A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.
• Normal healthy adult subjects between 20-50 years of age.
• Body weight within 80-120% of ideal body weight.
‣ Male Ideal body weight = (height - 80) x 0.7
⁃ Female Ideal body weight = (height - 70) x 0.6
• Acceptable medical history and physical examination including:
• normal ECG results within six months prior to dosing.
• no particular clinical significance in general disease history within two months prior to dosing.
• Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG), PT(INR) and OGSP.
• Acceptable hematology within two months prior to dosing, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
• Acceptable urinalysis within two months prior to dosing, which includes pH, blood, glucose and protein.
• Signed the written informed consent to participate in this study