Pharmacology: Bioequivalence study: Mydrephrine-P Ophthalmic Solution and the standard preparation (ophthalmic solution, tropicamide 0.5% / phenylephrine hydrochloride 0.5%) were tested using the two treatments, two periods, crossover design. One drop of each drug was instilled once into the conjunctival sac of healthy adult male subjects. Based on the result of statistical analyses performed using the maximum pupil diameter change before and after instillation, and the area under the pupil diameter change-time curve as parameters for judging bioequivalence, these two drugs were validated as bioequivalent. (See Table 2 and figure.)
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The values of the parameters of the differences in the maximum pupil diameter and the area under the differences in the pupil diameter time-curve may vary depending on the test conditions, including the selection of subjects, number of measurements, and timing of measurements.