Favorite Datasets from Early Phases of Drug Research

Bioequivalence Study

Part 3 - Table 5


Twenty-six healthy male subjects (Sub) were allocated randomly to one of two treatment sequences (Seq) in a two period crossover design. The objective of the trial was to determine if the pharmacokinetic characteristics of one 40 mg capsule of a drug made by Company A (A) are the same as the concurrent administration of two 20 mg capsules of the same drug made by Company B (B). The two treatment sequences were either treatment A in the first period followed by treatment B in the second period, or the reverse order. A five to seven day washout period separated the treatment periods. The pharmacokinetic variables area under the plasma concentration vs. time curve (AUC) and the maximum plasma concentration (Cmax) were calculated for each subject in each treatment period from drug levels assayed from plasma samples taken at 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post dose.

Return to top
Return to Favorite Datasets Index


Part 3 - Table 5
Bioequivalence Study
AUC Cmax
(ng*hr/ml) (ng/ml)
Sub Seq A B A B
4 A/B 1818.15 1425.94 767.01 786.82
5 A/B 961.01 1336.80 324.95 746.19
8 A/B 303.20 318.49 150.50 108.95
10 A/B 622.05 435.05 284.15 129.10
12 A/B 853.29 730.59 265.11 331.30
13 A/B 491.96 550.74 304.60 242.90
16 A/B 829.02 922.32 545.61 690.92
17 A/B 984.80 1513.92 352.61 924.03
19 A/B 536.49 890.33 312.09 453.18
22 A/B 578.87 537.25 479.21 342.88
25 A/B 1314.56 566.55 666.79 634.85
101 A/B 513.91 759.36 313.32 491.06
110 A/B 1875.32 2037.17 821.93 809.33
2 B/A 1921.46 1481.57 600.90 498.20
3 B/A 2440.17 2047.97 1052.48 809.55
6 B/A 364.33 252.54 156.26 82.89
7 B/A 1181.30 935.76 696.52 367.07
9 B/A 1564.24 1068.37 1223.06 830.10
11 B/A 6249.43 5383.08 1354.01 1846.17
14 B/A 579.89 1127.86 376.35 1567.81
15 B/A 1088.82 727.69 899.38 438.50
18 B/A 497.61 488.43 306.01 345.60
20 B/A 633.89 367.36 348.44 310.44
21 B/A 1111.07 947.20 445.17 418.90
23 B/A 807.18 299.39 464.48 171.05
26 B/A 486.44 395.26 207.21 145.74


Source:

Bradstreet, T.E. (1994) "Favorite Data Sets from Early Phases of Drug Research - Part 3." Proceedings of the Section on Statistical Education of the American Statistical Association.

Return to top
Return to Favorite Datasets Index


Send comments to: tshort@jcu.edu
Last modified July 27, 2010 - THS