Bioequivalence evaluation of two glyceryl trinitrate patches after 12-h usage in healthy volunteers.
The study objective was to determine the bioavailability and main pharmacokinetic parameters of glyceryl trinitrate (GTN, CAS 55-63-0) following cutaneous application of two different glyceryl trinitrate patches using a randomized cross-over design. The two patches investigated were Deponit 5 (a newly developed test patch) and an already marketed reference patch. Thirty-seven healthy male volunteers were included in this study; 36 of them completed the investigation. Blood samples were withdrawn up to 15 h after start of patch application and plasma concentrations of glyceryl trinitrate were quantified by a GC/MS method. For the areas under the curve from time 0 to the last quantifiable sample, AUC(O-Tlast), mean values 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 patch). The statistical comparison (ANOVA, confidence intervals) of the pharmacokinetic parameters found in the study resulted in bioequivalence of both patches. Typical side-effects known and described under glyceryl trinitrate therapy were also observed in this study.
L.A.B. Gesellschaft für Pharmakologische Untersuchungen mbH & Co., Neu-Ulm, Fed. Rep. of Germany.
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V
Hutt
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Sauter
G
G
Pabst
R
R
Bonn
E
E
Fritschi
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D008297:Male; D005996:Nitroglycerin / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D005996:Nitroglycerin