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

Summary

To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.

Eligibility

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, gastrointestinal/hepatic, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
* History of allergic response(s) to acetaminophen, mannitol, sucralose or related drugs.
* History of clinically significant allergies including drug allergies or allergic bronchial asthma.
* Evidence of chronic or acute infectious diseases.
* Any clinically significant illness or surgery during the two month prior to dosing (as determined by the clinical investigator).
* Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
* Receiving any investigational drug within one month prior to dosing.
* Taking any prescription medication or any nonprescription medication within two weeks prior to dosing.
* Donating greater than 150 ml of blood within two months prior to dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to dosing.
* Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
* Any other medical reason as determined by the clinical investigator.
* Subject is pregnant or breastfeeding.
* Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, intrauterine device (IUD), barrier device or abstinence) throughout the study.

Conditions3

Browse More Trials