The influence of food on the bioavailability of a slow release theophylline preparation.
Food-induced changes in the absorption of Theostat 300, a controlled release formulation of theophylline, have been studied in healthy volunteers. This open, randomised, 3-way, single-dose study involved 12 volunteers who received the drug either while fasting, or with a standardised low-fat (10g), or high-fat (60g) breakfast. Each subject was studied over a 3-week period, with 3 separate days of oral treatment and a 7-day washout period between treatments. The results showed no differences in AUC0-24 and tmax values between the 3 kinds of diet. The only differences observed concerned absorption. Food intake increased Cmax values by 20%. The steady-state peak concentration obtained by means of simulated plasma levels was not influenced by food intake. This slight food-drug interaction of Theostat 300 seemed to be of no clinical significance.
Thebault
J J
JJ
A.S.T.E.R. Hôpital Cognacq-Jay, Paris.
Aiache
J M
JM
Mazoyer
F
F
Cardot
J M
JM
D000328:Adult; D003692:Delayed-Action Preparations; D005502:Food; D006801:Humans; D008297:Male; D013806:Theophylline / Q000008:administration & dosage / Q000493:pharmacokinetics*
D003692:Delayed-Action Preparations; D013806:Theophylline