A BIOEQUIVALENCE STUDY OF 2 BRANDS OF CAPTOPRIL TABLETS

Captopril, usually given in conjunction with thiazide diuretics, has b een used for the treatment of severe hypertension. The bioequivalence of two pharmaceutical formulations of captopril-Cardiopril (25-mg tabl ets), manufactured by Bir Zeit Pharmaceutical Company, and Capoten (25 -mg tablets), manufactured by Squibb Pharmaceuticals-was assessed in 1 2 healthy men. Both products were given orally on two occasions, separ ated by a 1-week washout period. Blood samples were taken for 10 hours after drug administration to determine plasma captopril concentration s. Changes in blood pressure were also measured after each treatment. Plasma captopril concentrations were measured by an enzyme-linked immu nosorbent assay procedure. No significant differences occurred at the 95% confidence level in oral absorption, maximum plasma level, time to maximum plasma level, absorption half-life, and area under the curve between Cardiopril and Capoten. The two products also produced similar changes in blood pressure profiles. Cardiopril and Capoten are bioequ ivalent and produce similar pharmacologic effects.