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Table 1 Characteristics and peak recorded serum APAP-CYS concentrations for subjects administered 4 g/day of acetaminophen during three clinical trials.

From: Acetaminophen-cysteine adducts during therapeutic dosing and following overdose

  Study
  Trial 1 Trial 2 Trial 3
Subjects Non-drinkers Moderate drinkers Alcoholics
Duration of dosing 10 d 10 d 5 d
Days of sampling 0, 4, 7, 9, 11,14 0,11 0, 2, 4, 6,7
n 24 91 APAP
47 placebo
40 APAP/
7 placebo
Median age (range) years 34.5 (23 to 63) 30 (21 to 64) 46 (33 to 66)
Male 7 (29%) 47 (52%) 39 (98%)
ALT    
Baseline ALT
Median (Range) IU/L
24 (14 to 45) 19 (11 to 49) 29 (10 to 178)
Peak ALT
Median (Range) IU/L
45 (19 to 136) 25 (14 to 128) 47.5 (8 to 238)
ALT >ULN during study
n (%)
14 (58%) 17 (19%) 24 (60%)
Peak Serum APAP-CYS    
   Mean (SD) nmol/L 0.4 (0.20) 0.1 (0.09)* 0.3 (0.12)
   Range nmol/L 0.1 to 1.0 0.0 to 0.5 0.1 to 0.8
  1. Trial 1 included non-drinkers treated for 10 days, Trial 2 included moderate drinkers treated for 10 days and Trial 3 included alcoholic subjects treated for five days. APAP-CYS-Acetaminophen-cysteine adducts, ALT-alanine aminotransferase, ULN-upper limits of normal for the test. SD-standard deviation.
  2. *p < 0.001 vs Trial 1 and 3