Bioequivalence assessment of a pregabalin capsule and oral solution in fasted healthy volunteers: a randomized,
Howard N Bockbrader1, Christine W Alvey, Brian W Corrigan
1Parke Davis Pharmaceutical Research, Ann Arbor, MI, USA. howard.bockbrader@a2pg.com
Objective:
To determine the oral bioavailability of a pregabalin capsule relative to a pregabalin solution.
Methods:
This was an open-label, randomized, crossover study in 12 healthy volunteers. Pharmacokinetics were compared for a 100-mg capsule and a 100-mg capsule dissolved in water, administered fasted.
Results:
Mean Cmax and AUC0-∞ for the capsule were within 2% of those for the solution (3.8 vs. 3.7 μg/ml and 26.7 vs. 27.0 μg×h/ml, respectively). The 90% confidence intervals for the ratios of Cmax and AUC0-∞ fell fully within 80 - 125%.
Conclusions:
A 100-mg pregabalin capsule is bioequivalent to a pregabalin solution (100-mg capsule dissolved in water).
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