Dabigatran etexilate (DE), converted to active dabigatran in the body, is administered orally. Its availability in the body is dependent on the acidity of the stomach.

The current study shows that in healthy young subjects, with a consistently acidic environment in the stomach, there are no significant differences in the blood levels of dabigatran after taking the new DE tablet versus the existing drug capsule.

However, the amount of dabigatran found in the circulation was reduced by about 70% when the tablet was given to healthy young individuals pretreated with a stomach-acid–reducing drug. This diminished availability in the blood may result in a high risk of drug failure in elderly patients, who often experience an elevated gastric pH. Hence, when developing a new formulation of a drug with pH-dependent solubility such as DE, investigating the effect of agents that neutralize stomach acid should be considered, even though current regulations do not consistently mandate these investigations in clinical trials.