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Comparison of choline theophyllinate and theophylline gastric irritation utilizing gastric potential difference as a model.

Choline theophyllinate and theophylline were administered to 14 healthy volunteers following which the irritant effects of each drug were determined by measuring changes in gastric potential difference (GPD). Theophylline was found to be 2 and 3 times more irritating than choline theophyllinate in terms of mean membrane instability time and mean irritation index parameters, respectively. Considerations after the study indicated that the crossover design utilized was an efficient study design for the GPD model.