Effect of food on the bioavailability of a slow-release theophylline formulation.

A study was conducted in two groups of healthy volunteers to assess whether the time of administration (10 min before the meal versus 60 min after the meal) influences the pharmacokinetics and absorption kinetics of a slow-release theophylline product (Teonova). In the first group (Group A, n = 10), the drug was given in a paired-sample design as a single dose of 600 mg before and after breakfast with an interval of at least 1 week between the two administrations. In the second group (Group B, n = 10), Teonova was given by the same study design before and after dinner. In all cases, time curves of theophylline plasma levels were determined by collecting serial blood samples 24 h after dosing and analysed pharmacokinetically through model-independent methods. In Group A, curves obtained before and after the meal were fully superimposable, and no difference was found between the pharmacokinetic parameters determined in either condition. The same result was obtained in Group B. Our results indicate that, after single dose, the two different times of administration that we tested were equivalent in pharmacokinetic terms.