The effect of diet on the efficacy onset and duration of action of procaterol hydrochloride tablets.
Procaterol hydrochloride, a new potent beta-2 agonist drug, was evaluated for effects of food absorption, onset of action, and efficacy in a single-dose non-blinded placebo controlled crossover design in 18 subjects. Three diet conditions, separated by a three to seven day washout period, were used and compared to a placebo treatment. The diets were standardized and included high fat, low fat, and a fasting condition. Spirometric determinations and vital signs were obtained at 0, 15, 30 minutes, and at one, two, four, six, eight hours post-dose to evaluate therapeutic availability since no technique for measuring serum levels of procaterol hydrochloride is currently available. Spirometry results indicated significant improvement in pulmonary function during all diet conditions except with the placebo treatment. A delay in onset of action was seen in the low fat diet and to a certain extent in the high fat diet as compared to the fasting condition. There was no effect of diet on procaterol hydrochloride's peak response or duration of action with improvement in pulmonary function demonstrated for up to eight hours. Tremor and headache were the most frequent side effects, and were mild and transient. No significant effects were noted in electrocardiograms, heart rate, or blood pressure. An elevation in serum glucose was seen in three subjects during the fasting challenge and was felt to be secondary to the beta-agonist effects of procaterol hydrochloride. Procaterol was found to be an effective drug with a delayed onset of action when administered with food, but no effect on subsequent efficacy or duration of action.