RELATIVE BIOAVAILABILITY OF TWO FORMULATIONS CONTAINING 40MG OF PANTOPRAZOLE UNDER FASTING AND POSTPRANDIAL CONDITIONS

• DOI: 10.22533/at.ed.159222217018

• Palavras-chave: Bioequivalence; postprandial and fasting; delayed release; CLUE-EM/EM

• Keywords: Bioequivalence; postprandial and fasting; delayed release; CLUE-EM/EM

• Abstract:

  The aim of this study was to evaluate the bioequivalence between two formulations of delayed-release tablets containing 40 mg of pantoprazole. The products were administered to healthy volunteers as a single dose under fasting (2x2 inbred; n=48) and postprandial (2x4 fully replicated inbred; n=80) conditions with washout of 7 days. Plasma pantoprazole concentrations were determined by ultra-performance liquid chromatography coupled with tandem mass spectrometry. After logarithmic transformation of the experimentally found plasma concentrations, the pharmacokinetic parameters used in the bioequivalence calculation were obtained: Cmax e ASC0-t. The 90% confidence interval for the ratios of the geometric means between the test drug and the reference drug, for the parameters Cmax e ASC0-t, are comprised in the IC 90% between 80%-125%. It is concluded that the formulations are bioequivalent, in terms of speed and extent of absorption of the active in the body, in both conditions studied, therefore interchangeable.

• Número de páginas: 12