Comparative Bioavailability of Two Test Brands of Theophylline; Tablets and A Reference Quibron®-T/Sr Under Fasting and Limited Food Conditions

Comparative bioavailabilities of two test formulations containing 300 mg Theophylline/sustained release tablets were compared with a reference Quibron®-T/SR 300 mg/SR tablet of Mead Johnson. From the concentration-time profiles, the primary pharmacokinetic parameters were evaluated under fasting and under limited food effect conditions in healthy subjects (N=24). The statistical evaluation of the average pharmacokinetic parameters of AUC0, AUC0‡t and Cmax, demonstrated lack of statistically significant difference between the average pK characteristics from two test formulations versus the reference. The study demonstrated the absence of food effect on Theophylline disposition.