Bioequivalence assessment of a pregabalin capsule and oral solution in fasted healthy volunteers: a randomized, crossover study.
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).
Parke Davis Pharmaceutical Research, Ann Arbor, MI, USA. howard.bockbrader@a2pg.com
Howard N
HN
Bockbrader
Christine W
CW
Alvey
Brian W
BW
Corrigan
Louis L
LL
Radulovic
D000284:Administration, Oral; D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000493:pharmacokinetics*; D002214:Capsules; D018592:Cross-Over Studies; D005215:Fasting; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069583:Pregabalin; D013810:Therapeutic Equivalency; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics
D000700:Analgesics; D002214:Capsules; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid