ddI EC (Videx) study confirms and clarifies dosing on an empty stomach

The significance and importance of assuring that Videx EC (enteric coated ddI) is taken on an empty stomach were addressed in a poster presented at the 41st ICAAC that summarized four studies that were designed to assess the effect of food and timing of meals on the bioavailability of Videx EC.

The four studies involved a total of 334 patients and were open label, single dose, randomised, crossover studies conducted in healthy subjects. In these studies, 400mg of Videx EC was given with a high fat meal (757 calories), light meal (373 calories), yoghurt (69 calories), or applesauce (25 calories).

The high-fat meal, light meal, yoghurt, and applesauce decreased the Cmax of Videx EC by 46%, 22%, 30%, and 24%, respectively, and lowered the AUC by 19%, 27%, 20%, and 18%, respectively. If the Videx EC was given 1 hour before a meal, Cmax and AUC were lower by 15% and 24%, respectively, and for 2 hours after a meal, were lower by 15% and 10%, respectively. For 1.5, 2, and 3 hours before meals, Cmax values were unchanged but AUC was lower by 10%, 4%, and 0%, respectively.

There were no deaths or serious adverse events in the studies. These data reaffirm the current dosing recommendations regarding Videx EC: It appears that taking Videx EC at least 1.5 hours before or 2 hours after a meal are sufficient to achieve Videx EC concentrations equivalent to those achieved with fasting.

B.D. Damle and others. Effect of Food on Oral Bioavailability of Didanosine from Delayed Release Capsules Containing Enteric Coated Beads. Abstract A-499.