Download PDF
Arzneimittelforschung 2008; 58(9): 451-456
DOI: 10.1055/s-0031-1296538
Antiemetics · Gastrointestinal Drugs · Urologic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Bio equivalence Study of Two Enteric-coated Formulations of Pantoprazole in Healthy Volunteers under Fed Conditions

Augusto Filipe
1   Medical Department, Grupo Tecnimede, Prior Velho, Portugal
,
Susana Almeida
1   Medical Department, Grupo Tecnimede, Prior Velho, Portugal
2   Department of Pharmacology and Therapeutics, Universidad Autònoma de Barcelona, Barcelona, Spain
,
Ana Cristina Franco Spínola
1   Medical Department, Grupo Tecnimede, Prior Velho, Portugal
,
Rita Neves
1   Medical Department, Grupo Tecnimede, Prior Velho, Portugal
,
Fethi Trabelsi
3   Anapharm, Québec City, Québec, Canada
,
Alex Torns
4   Anapharm Europe S.L., Barcelona, Spain
,
Eric Shink
3   Anapharm, Québec City, Québec, Canada
› Author Affiliations
Further Information

Publication History

Publication Date:
19 December 2011 (online)

    Permissions and Reprints

Abstract

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 C max (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.

Key words

CAS 102625-70-7 - Pantoprazole, bioequivalence, pharmacokinetics - Proton pump inhibitors
 

  • References

  • 1 Jungnickd PW. Pantoprazole: A New Proton Pump Inhibitor. Clin Ther. 2000; 22 (11) 1260-1293
    PubMedGoogle Scholar
  • 2 Cheer SM, Prakash A, Faulds D, Lamb HM. Pantoprazole: an update of its pharmacological properties and therapeutic use in the management of acid-related disorders. Drugs. 2003; 63 (1) 101-132
    CrossrefPubMedGoogle Scholar
  • 3 Klotz U. Pharmacokinetic considerations in the eradication of Helicobacter pylori. Clin Pharmacokinet. 2000; Mar 38 (3) 243-270
    CrossrefPubMedGoogle Scholar
  • 4 Tanaka M, Ohkubo T, Otani K, Suzuki A, Kaneko S, Sug-awara K et al. Stereoselective pharmacokinetics of pantoprazole, a proton pump inhibitor, in extensive and poor metabolizers of S-mephenytoin. Clin Pharmacol Ther. 2001; 69: 108-113
    CrossrefPubMedGoogle Scholar
  • 5 Boparai V, Rajagopalan J, Triadafilopoulos G. Guide to the Use of Proton Pump Inhibitors in Adult Patients. Drugs. 2008; 68 (7) 925-947
    CrossrefPubMedGoogle Scholar
  • 6 Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98. July 2001.
    PubMed
  • 7 Committee for Proprietary Medicinal Products (CPMP). Note for guidance on modified release oral and transder-mic dosage forms: section II (pharmacokinetic and clinical evaluation). CPMP/EWP/280/96. July 1999.
    PubMed
  • 8 Data on file, Medical Department, Grupo Tecnimede, Portugal, 2007.
    PubMed
  • 9 Good Clinical Practice Consolidated Guideline. International Conference on Harmonisation, E6. 1996.
    PubMed
  • 10 Committee for Proprietary Medicinal Products (CPMP). Note for guidance on modified release oral and transder-mic dosage forms: section II (pharmacokinetic and clinical evaluation). CPMP/EWP/280/96. July 1999.
    PubMed
  • 11 Guidance on pantoprazole sodium. Food and Drug Administration (FDA), May 2008.
    PubMed
  • 12 Center for Drug Evaluation and Research (CDER) –Food and Drug Administration (FDA). Guidance for industry: food-effect bioavailability and fed bioequivalence studies. December 2002.
    PubMed
  • 13 de Campos DR, Vieira NR, Bernasconi G, Barros FA, Meurer EC, Marchioretto MA et al. Bioequivalence of two enteric coated formulations of pantoprazole in healthy volunteers under fasting and fed conditions. Arzneimittel-Forschung (Drug Research). 2007; 57 (6) 309-314
    Article in Thieme ConnectPubMedGoogle Scholar
  • 14 Mendes FD, Patni AK, Reyer S, Monif T, Moreira LD, Ilha JO et al. Comparative bioavailability study with two pantoprazole delayed-released tablet formulations administered with and without food in healthy subject. A Arzneimittel-Forschung (Drug Research). 2008; 58 (3) 141-148
    PubMedGoogle Scholar
  • 15 CHMP Efficacy Working Party: Therapeutic Subgroup on Pharmacokinetics. Questions and Answers on the Bioavailability and Bioequivalence Guideline. EMEA/CHMP/EWP/40326/2006.
    PubMed