A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study… (NCT05563961) | Clinical Trial Compass
UnknownNot Applicable
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
Taiwan48 participantsStarted 2022-10-28
Plain-language summary
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.
Who can participate
Age range20 Years – 50 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years.
* A clinically significant disorder involving the allergy, cardiovascular, respiratory, renal, gastrointesti…