Abstract
The steady-state blood levels of a reformulated Theophylline sustained release tablet formulation (Quibron-T/SR®) were compared with Theo-dur® tablets 300mg SR. Statistical analysis was performed, using the two one-sided tests procedure, on the In-transformed values of maximum 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 variance on rank transformed values. In every case, the reformulated test treatment was found within the limits required to demonstrate bioequivalence.
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