BIOEQUIVALENCE EVALUATION OF 2 GLYCERYL TRINITRATE PATCHES AFTER 12-HUSAGE IN HEALTHY-VOLUNTEERS

The study objective was to determine the bioavailability and main phar macokinetic parameters of glyceryl trinitrate (GTN, CAS 55-63-0) follo wing cutaneous application of two different glyceryl trinitrate patche s using a randomized cross-over design. The two patches investigated w ere Deponit(R) 5 (a newly developed test patch) and an already markete d reference patch. Thirty-seven healthy male volunteers were included in this study; 36 of them completed the investigation. Blood samples w ere withdrawn up to 15 h after start of patch application and plasma c oncentrations of glyceryl trinitrate were quantified by a GC/MS method . For the areas under the curve front time 0 to the last quantifiable sample AUC(O-T-last), mean vales of 1545 (test patch, n = 35) and 1686 h.pg/ml (reference patch, n = 35) were found. The corresponding peak glyceryl trinitrate plasma levels were 253 and 263 pg/ml, respectively , they were reached after 6.58 h (test patch) and 7.72 h (reference pa tch). The statistical comparison (ANOVA, confidence intervals) of the pharmacokinetic parameters found in the study resulted in bioequivalen ce of both patches. Typical side-effects known and described under gly ceryl trinitrate therapy were also observed in this study.