Table 1.
Characteristics and peak recorded serum APAP-CYS concentrations for subjects administered 4 g/day of acetaminophen during three clinical trials.
| 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 |
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.
*p < 0.001 vs Trial 1 and 3