Pharmacokinetic evaluation of rofecoxib : comparison of tablet and suspension formulations.

OBJECTIVE: Rofecoxib suspension is a formulation developed to increase the convenience of rofecoxib therapy for patients who have difficulty swallowing tablets. This open-label, two-part study compared the single-dose pharmacokinetics of rofecoxib tablets and rofecoxib suspension in healthy subjects. DESIGN AND STUDY PARTICIPANTS: Part I was a two-period crossover study that assessed the bioequivalence of the 12.5mg/5mL rofecoxib suspension and the 12.5mg rofecoxib tablet in 24 healthy subjects (12 men and 12 women). Part II was a crossover study in 24 additional healthy subjects (12 men and 12 women) that determined the bioequivalence of the rofecoxib 25mg/5mL suspension and the 25mg rofecoxib tablet.
RESULTS: No clinically meaningful differences between rofecoxib tablet and suspension were apparent with respect to the rofecoxib area under the concentration-time curve from time zero to infinity (AUC(0-infinity)) and maximum plasma concentration (C(max)), the primary measures of bioequivalence. At the 12.5mg and 25mg doses, the 90% CI for the geometric mean ratio (suspension/tablet) of both AUC(0-infinity) and C(max) fell within the prespecified interval for bioequivalence (0.80-1.25).
CONCLUSIONS: The rofecoxib suspension is bioequivalent to the rofecoxib tablet at single oral doses of 12.5mg and 25mg in healthy volunteers. The convenience and ease of administration of rofecoxib suspension may translate into increased compliance with therapy compared with a conventional solid tablet formulation, particularly for elderly patients.

RCT Entities:   Population Interventions Outcomes