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.

- As measured by AUC and Cmax, is the single 40 mg capsule manufactured by Company A the same pharmacokinetically as the two concurrently administered 20 mg capsules manufactured by Company B?

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Part 3 - Table 5 |
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Bioequivalence Study |
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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 |

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Last modified July 27, 2010 - THS