COMPARATIVE PHARMACOKINETICS AND BIOEQUIVALENCE OF 2 THEOPHYLLINE 300-MG SUSTAINED-RELEASE FORMULATIONS AT ORAL DOSING STEADY-STATE

The steady-state blood levels of a reformulated Theophylline sustained release tablet formulation (Quibron-T/SR(R)) were compared with Theo- dur(R) tablets 300mg SR. Statistical analysis was performed, using the two one-sided tests procedure, on the ln-transformed values of maximu m Theophylline plasma concentrations, trough plasma concentrations and Area Under the plasma concentration - time Curve. Data regarding Time to reach maximum plasma concentration were analyzed by analysis of va riance on rank transformed values. In every case, the reformulated tes t treatment was found within the limits required to demonstrate bioequ ivalence.