To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers.
Acetaminophen (AAP) is the most popular used analgesic/ antipyretic drug with serious hepatotoxic adverse effects; suicidal or unintentional overdose of AAP-induced hepatotoxicity. Cytochrome P450 2E1 (CYP2E1) is thought contribute to the responsible reactive metabolite N-acetyl-p-benzoquinone (NAPQI) of AAP overdose-induced hepatotoxicity. Pharmaceutical excipients are inactive ingredients that are added to a pharmaceutical compound. The objective of this study was to investigate the possible response of Panadol® (AAP alone) and SafeTynadol® (AAP with various selected excipients combination) formulations, while observing the AAP toxic metabolites (AAP-Cys) circumstances change in healthy volunteers. According to the current safety data, could be potentially develop hepatotoxicity-free AAP new formulation drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
28
Acetaminophen 500mg Tablet
Acetaminophen 500mg Tablet
Tri-Service General Hospital
Taipei, Neihu District, Taiwan
Percentage change from baseline of ALT peak level within study periods
ALT peak level in blood after administration
Time frame: Blood samples were collected on days 2-7 (before dosing)
- Incidence of peak ALT elevations > 1X ULN within study periods;
The blood concentration of ALT.
Time frame: Day 1-7
- Incidence of peak ALT elevations > 2X ULN within study periods;
The blood concentration of ALT.
Time frame: Day 1-7
- Incidence of peak ALT elevations > 3X ULN within study periods;
The blood concentration of ALT.
Time frame: Day 1-7
- Incidence of peak ALT elevations > 5X ULN within study periods;
The blood concentration of ALT.
Time frame: Day 1-7
- Incidence of peak ALT elevations > 8X ULN within study periods;
The blood concentration of ALT.
Time frame: Day 1-7
- Incidence of total bilirubin ≥ 2.5mg/dL within study periods;
The blood concentration of total bilirubin.
Time frame: Day 1-7
- Hepatic failure rate (hepatic encephalopathy, ascites, total bilirubin ≥ 2.5mg/dL or liver transplantation) within study periods;
The blood concentration of hepatic encephalopathy, ascites, total bilirubin.
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Time frame: Day 1-7
- The time-interval weighted area under the curve (AUC) of free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts within study periods.
The blood concentration of free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts
Time frame: Day 1-7
- The time-interval weighted area under the curve (AUC) of ALT level within study periods
The blood concentration of ALT.
Time frame: Day 1-7