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
| Â | Study | ||
|---|---|---|---|
| Â | 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 | Â | Â | Â |
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 | Â | Â | Â |
   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 |