1st Phase Test of Disopyramide Phosphat Retard Tablet:After 3 Consecutive Administrations and 1 Week Consecutive Administration

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A Phase I Study was carried out on disopyramide phosphate retard (slow-release) tablets in healthy Japanese subjects, employing Rythmodan® capsules as the control drug. The safety and pharmacokinetics of disopyramide phosphate were investigated. This study was carried out by the cross-over method: the subjects were first administered three doses (at 12-hour intervals) of disopyramide phosphate for each of the 150 mg, 200 mg, and 250 mg retard tablet preparations; they were then administered four doses (at 8-hour intervals) of Rythmodan®, i. e., one 100 mg capsule each time. After that, using new subjects, a one-week multiple-dosing study was conducted on disopyramide phosphate, administering one 200 mg tablet every 12 hours. As a result, no striking abnormalities were detected in terms of the subjective symptoms, vital signs, electrocardiogram (ECG), auscultatory percussion examination or laboratory tests. The peak serum concentration occurred 2 hours after the administration of one 100 mg capsule, 4-6 hours after the administration of one retard tablet, and at 4 hours in the case of multiple-dosing with retard tablets. The urinary excretion of the drug is slower in the case of three consecutive administrations of the retard tablets than four doses of the capsules, and the amount of excretion in the case of the retard tablets was reduced because of retention in the body until reaching a steady state. In the case of multiple-dosing of the 200 mg retard tablets for one week, a steady state was reached in about 3 days. The above results confirmed the pattern of the serum concentration and the safety of disopyramide phosphate, administered in the form of 150, 200, and 250 mg retard tablets. It was therefore concluded that there are no impediments to the performance of Phase II Study on this drug preparation.
一般社団法人日本臨床薬理学会の論文

1st Phase Test of Disopyramide Phosphat Retard Tablet:After 3 Consecutive Administrations and 1 Week Consecutive Administration

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