The possible influence of the food and fat content of meals on the bio
availability and pharmacokinetics of a 350 mg sustained release theoph
ylline (CAS 58-55-9) preparation (Bronchoretard(R)) was investigated a
fter single dose oral administration to 18 volunteers in a randomised
3-way crossover design. The treatments investigating administration of
the test preparation in a fasting state, after a standard meal and af
ter a high-caloric fat evening meal, according to commonly applied rul
es, were shown to be equivalent with respect to the extent of bioavail
ability (AUC) and the observed maximal concentration (C-max). Pharmaco
kinetic parameters describing sustained release characteristics were n
ot changed to any relevant degree. As expected, the co-administration
of food resulted in a physiologically determined delay in absorption,
which is probably not therapeutically relevant during long-term admini
stration.