Comparative two-phase clinicopharmacological trial of a new antihistaminic, EGYT-2062, setastine.

During the two-phase clinicopharmacological trial in humans of a new antihistaminic compound EGYT-2062, setastine developed by EGIS Pharmaceutical Company, Budapest, was tested the tolerance to the drug, its pharmacodynamic effect by i. c. histamine and acetylcholine tests, and its effect on the CNS by neuropsychiatric examination on eight healthy volunteers. The side-effects appearing during treatment were recorded. A self-controlled blind study was performed. The reference compound was clemastine. Based on the results, for prolonged use a dose of 2 mg three times/day (t.i.d.) is recommended. The antihistaminic effect of setastine almost equalled that of clemastine given in a dose of 1 mg t.i.d., while its antiacetylcholine effect exceeded it, and in view of its few psychic side-effects, might be tolerated better than clemastine.