Bioequivalence study of a new tablet formulation of triamterene and hydrochlorothiazide

Abstract

A three-treatment, single-dose, crossover bioequivalence study was conducted in healthy volunteers to compare urinary drug recovery following administration of hydrochlorothiazide tablets, the currently marketed capsule formulation of triamterene and hydrochlorothiazide (Dyazide), and a new tablet preparation of these active ingredients (Maxzide). No significant differences were observed in the urinary recovery of hydrochlorothiazide after the administration of hydrochlorothiazide tablets and Maxzide tablets. However, only about one-half as much hydrochlorothiazide was recovered following the administration of Dyazide capsules. Similarly, the urinary recovery of triamterene and the sulfate ester of hydroxy-triamterene after administration of Dyazide capsules was approximately one-half the levels observed after giving the new tablet formulation. The clinical consequences of the limited bioavailability of the active ingredients of Dyazide are discussed.