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.

• For either Drug A, its metabolite, or Drug B, does giving Drugs A and B as a single tablet differ from giving two tablets concurrently; one for Drug A and one for drug B?
• Is the combination tablet the same as the concurrent administration?