The tolerability of multiple oral doses of Pulsincap™ capsules in healthy volunteers

Abstract

Twelve healthy subjects entered a double-blind placebo-controlled parallel group study to evaluate the tolerability of a 28 day course of twice daily dosage with Pulsincap TM capsules having the plug set for separation after 6 h. Eight subjects received Pulsincap TM capsules and four subjects received a matching placebo capsule. There was no active medication in any of the study capsules. Daily assessments were made of adverse events. Laboratory safety data (bloods and urine) and faecal occult blood were monitored weekly. Subjects returned for a post-study medical check during the fortnight following their final treatment session. All subjects completed their dosing schedule satisfactorily. Eleven adverse events were reported by six of the eight subjects in the Pulsincap TM capsule group and 14 adverse events were reported by the four subjects taking placebo. None of the adverse events in either group was considered to be causally related to treatment. Four males, but no females, had at least one positive test for faecal occult blood, two in the Pulsincap TM capsule group and two in the placebo group. In the single subject for whom the test was positive repeatedly, the occult blood was associated in time with an intercurrent dental problem and its treatment. Pulsincap TM capsules were well tolerated by the eight subjects who received them and there was no evidence of adverse events being causally related to this formulation. The results of this tolerability study support the further development of the Pulsincap TM formulation for delivery of active drugs.