Favorite Datasets from Early Phases of Drug Research

Combination Therapy Bioequivalence Study

Part 3 - Table 7


Sixteen healthy male subjects (Sub) were allocated randomly to one of two treatment sequences in a two period crossover design. The objective of the trial was to determine if the pharmacokinetics of a single tablet combination (C) of Drugs A and B as manufactured by one drug company are the same as those for two separate (S) but concurrent tablet administrations of Drugs A and B as manufactured by another drug company. The two treatment sequences were either separate tablets in the first period followed by the combination tablet in the second period, or the reverse order. A seven day washout period separated the two 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 for Drug A, its metabolite, and Drug B, from the plasma of blood samples taken at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, and 30 hours post dose.

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Part 3 - Table 7
Combination Therapy Bioequivalence Study
Drug A Metabolite Drug B
AUC Cmax AUC Cmax AUC Cmax
(ng*hr/ml) (ng/ml) (ng*hr/ml) (ng/ml) (ng*hr/ml) (ng/ml)
Sub Seq C S C S C S C S C S C S
1 S/C 493.62 582.11 243.1 333.0 3108.40 2888.52 494.8 459.3 298.52 368.37 39.4 65.2
4 S/C 645.78 552.67 285.8 143.5 1667.97 1558.98 168.8 133.4 411.09 456.08 82.8 54.5
6 S/C 508.33 465.43 378.7 290.3 1668.81 1915.03 265.9 337.6 363.81 331.09 53.1 53.0
7 S/C 563.36 597.42 115.1 347.5 2151.54 2060.68 198.3 192.1 397.08 405.17 54.7 81.8
9 S/C 357.33 405.31 142.3 201.3 1146.28 1236.48 84.8 103.8 452.10 669.55 68.8 107.3
11 S/C 233.28 258.80 102.1 151.4 1377.62 1649.46 140.0 189.2 417.32 661.40 43.2 62.6
13 S/C 326.40 338.01 139.3 278.6 2764.74 2707.75 355.5 357.4 500.91 593.49 67.3 79.0
15 S/C 313.52 276.35 165.0 167.7 2033.78 2102.87 183.3 212.1 431.55 417.19 73.0 81.5
2 C/S 382.21 370.89 246.2 180.8 2348.63 2181.62 303.9 245.7 526.03 509.83 99.3 76.3
3 C/S 435.09 447.63 212.4 173.3 2773.75 2783.86 360.7 354.3 379.20 603.85 80.6 85.6
5 C/S 689.09 514.11 357.3 172.4 3575.11 2922.28 503.7 315.0 526.00 469.37 131.2 100.2
8 C/S 372.61 343.09 174.5 356.2 2588.72 2456.53 313.3 348.5 439.16 350.74 80.7 56.2
10 C/S 450.85 407.61 298.3 211.8 2256.81 2220.35 335.1 306.3 508.40 591.89 90.3 78.1
12 C/S 503.59 486.86 333.9 137.2 2520.15 2237.74 356.0 277.5 417.03 426.69 93.2 65.9
14 C/S 686.34 643.01 308.7 398.1 2958.28 3072.02 306.2 296.8 455.71 501.08 55.8 73.4
16 C/S 332.50 331.50 303.7 135.7 2280.09 2078.79 272.8 241.9 512.46 568.80 55.9 63.1


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.

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Last modified July 27, 2010 - THS