Bioequivalence study of two enteric-coated formulations of pantoprazole in healthy volunteers under fed conditions.
This study was conducted in order to assess the bioequivalence of two enteric-coated formulations of 40 mg pantoprazole (CAS 102625-70-7), under fed conditions. Seventy-four healthy subjects, age ranging from 24 to 55 years, were enrolled in a two-centre, randomised, single-dose, open-label, 2-way crossover study, with a minimum washout period of 7 days. Plasma samples were collected up to 30.0 h post-dosing. Pantoprazole levels were determined by reverse liquid chromatography and detected by tandem mass spectrometry detection (LC-MS/ MS). Pharmacokinetic parameters used for bioequivalence assessment were the AUClast (area under the concentration-time curve from time zero to time of last observed non-zero concentration), AUCinf (area under the concentration-time curve from time zero to infinity) and Cmax, (maximum observed concentration). These parameters were determined from the pantoprazole concentration data using non-compartmental analysis. Gender-related differences were found in the variability of all relevant pharmacokinetic parameters. The 90% CI (90% confidence intervals), obtained by analysis of variance (ANOVA) were within the predefined ranges. Bioequivalence between the test and reference formulation, under fed conditions, was concluded both in terms of rate and extent of absorption.
Filipe
Augusto
A
Medical Department, Grupo Tecnimede, Prior Velho, Portugal. dmed.ct.tecnimede@mail.telepac.pt
Almeida
Susana
S
Franco Spínola
Ana Cristina
AC
Neves
Rita
R
Trabelsi
Fethi
F
Torns
Alex
A
Shink
Eric
E
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D004311:Double-Blind Method; D005215:Fasting / Q000378:metabolism; D005260:Female; D005502:Food; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D012189:Retrospective Studies; D013608:Tablets, Enteric-Coated; D013810:Therapeutic Equivalency
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D013608:Tablets, Enteric-Coated; D000077402:Pantoprazole