Favorite Datasets from Early (and Late) Phases of Drug Research

Alcohol Interaction Study in Men

Part 4 - Table 5

Twenty-three healthy male subjects completed a five period (Per) crossover study. Each subject followed one of 10 randomly allocated sequences (Trt Seq) of five treatments; either no treatment or one of four active treatments from the same drug class used to treat the same illness. A one-week washout period separated the treatment periods which were one week in length.

During each of the five treatment weeks, the subjects received one of the four active therapies or no treatment at all. On the evening of the last day of each treatment week, ethanol 0.3gm/kg body weight was given orally with orange juice (500 ml) over a period of 10 minutes one hour after the evening meal. Serum ethanol levels were assayed from blood samples collected from each subject at 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes following the ethanol intake. From these measurements, the area under the serum ethanol curve (AUC180), the maximum serum ethanol level (Cmax), and the time at which Cmax was observed (Tmax) were calculated for each of the five treatments. (Based upon advice from a pharmacokineticist, any serum ethanol level below the 2 mg/dl limit of detection was treated as a zero in the calculation of AUC180 and Cmax.)

When comparing each of the four active therapies to no treatment, a 20% difference in either Cmax or AUC would provide evidence of a drug- alcohol interaction.

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Part 4 - Table 5
Alcohol Interaction Study in Men
No Treatment Treatment 1 Treatment 2 Treatment 3 Treatment 4
Sub Race Seq Per Cmax AUC Tmax Per Cmax AUC Tmax Per Cmax AUC Tmax Per Cmax AUC Tmax Per Cmax AUC Tmax
1 N 1 4 26.02 33.90 0.33 1 22.96 28.17 0.50 2 33.56 40.94 0.50 5 19.54 30.46 0.75 3 19.91 27.04 0.50
2 N 5 1 17.37 19.60 0.33 2 15.64 15.47 0.33 5 12.92 15.85 0.75 3 19.22 24.34 0.50 4 12.00 11.31 0.33
3 N 4 2 10.95 15.62 0.75 5 13.36 17.66 0.75 3 10.74 13.77 0.50 4 13.86 18.02 0.50 1 16.08 20.24 0.75
4 N 9 3 34.99 43.12 0.50 2 22.59 33.12 0.33 5 19.82 32.11 1.00 4 23.00 35.17 0.50 1 22.32 32.34 0.33
5 N 7 5 11.81 21.95 1.00 4 15.04 26.76 0.75 1 12.61 17.98 0.50 3 15.24 25.17 0.75 2 16.11 30.60 0.75
6 N 2 3 25.95 37.12 0.33 4 26.42 32.77 0.75 1 17.70 15.72 0.50 2 24.89 34.92 0.50 5 27.34 35.35 0.50
7 N 8 2 25.77 34.79 0.50 5 18.89 31.52 1.00 4 34.02 30.06 0.33 1 17.29 18.37 0.75 3 21.26 34.26 0.50
8 N 10 1 4.99 8.10 1.00 3 10.87 16.22 1.00 2 9.75 10.45 0.50 5 10.35 17.18 1.50 4 11.79 19.67 1.00
9 N 3 5 10.80 15.18 0.50 3 10.98 11.10 0.50 4 14.79 15.45 0.50 1 7.65 8.14 0.50 2 7.96 7.84 0.17
10 N 6 4 8.79 12.59 0.50 1 12.82 15.42 0.33 3 15.30 28.78 1.00 2 12.95 22.16 0.75 5 13.62 24.99 1.00
11 N 4 2 12.61 15.92 0.75 5 13.08 19.93 1.00 3 7.04 7.21 0.75 4 20.75 28.92 0.50 1 14.71 15.87 0.50
12 N 3 5 8.37 8.08 0.33 3 8.15 7.71 0.50 4 17.16 23.57 0.50 1 7.07 8.27 0.33 2 7.83 9.66 0.75
13 N 10 1 6.39 9.78 0.75 3 14.68 21.53 0.50 2 15.38 22.56 1.00 5 14.37 22.33 0.75 4 13.46 24.13 0.50
14 N 2 3 21.64 37.46 0.75 4 17.35 24.28 0.33 1 18.32 27.68 0.50 2 30.68 54.70 0.75 5 19.94 41.05 1.00
15 A 6 4 19.17 27.98 0.50 1 13.05 17.04 0.75 3 16.48 22.05 0.75 2 14.32 21.70 0.75 5 13.26 18.13 0.75
16 A 9 3 7.45 7.43 1.00 2 8.40 8.48 0.50 5 6.36 7.19 1.00 4 10.68 9.11 0.50 1 10.55 14.76 1.00
17 N 1 4 7.28 9.71 1.00 1 7.78 8.93 0.50 2 15.01 23.57 0.75 5 14.49 21.04 0.50 3 13.42 18.19 1.00
18 A 5 1 13.34 12.92 0.50 2 11.57 16.37 0.75 5 11.97 13.83 0.75 3 6.49 7.85 0.17 4 14.24 16.33 0.50
19 N 7 5 12.27 19.30 1.00 4 8.45 13.27 1.00 1 8.85 11.94 1.00 3 12.98 16.90 0.75 2 9.52 16.18 1.00
20 N 8 2 13.51 14.47 0.33 5 22.31 29.95 0.50 4 22.27 29.10 0.50 1 13.29 19.31 0.50 3 17.89 17.31 0.50
21 A 1 4 8.27 7.07 0.50 1 7.34 11.24 1.00 2 0 0 NA 5 5.59 7.04 0.75 3 2.40 1.44 1.00
22 A 5 1 10.41 18.00 0.50 2 9.18 9.71 0.33 5 5.48 5.84 0.75 3 8.75 13.11 0.50 4 10.72 14.30 0.33
23 A 7 5 2.87 1.17 0.75 4 2.20 0.55 0.75 1 6.68 4.96 0.50 3 5.63 2.63 0.50 2 4.45 2.20 0.33

NA = Not applicable as Cmax=AUC=0

Source:

Bradstreet, T.E. and Liss, C.L. (1995) "Favorite Data Sets from Early (and Late) Phases of Drug Research - Part 4." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 27, 2010 - THS