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COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS

Year 1999, Volume: 12 Issue: 2, 74 - 78, 03.12.2016

Ece İskender Serhan Tuğlular Zafer Gören Rezzan Aker Ahmet Akıcı Atila Karaalp Neslihan Aslan Mehmet Koç Filiz Onat Emel Akoğlu Kemal Berkman Şule Oktay

Abstract

Objective: A comparative bioavailability study was established on two 40 mg tablets of famotidine (test product: Famodin 40 mg ilsan ilaçları A.Ş., Turkey; reference product: Pepdine 40mg, Merck, Sharp & Dohme, France) after the application of a single oral dose to twenty four healthy volunteers.
Methods: A two-way crossover randomized study applied to 12 female and 12 male subjects with a one- week wash-out period between two formulations. Blood samples were collected prior to (time zero) and at 14 time points within 24 hrs after dosing. Plasma concentrations of famotidine were determined via high performance liquid chromatographic method in France by CEPFIAC Bioanalytical Research Center.
Results: Absorption and disposition of famotidine after a single oral administration of 40 mg are comparable between the two formulations. Cmax values were determined as 174 ± 59 ng/ml and 151 ±49 ng/ml (90% confidence intervals 1.00-1.32), and AUCq.^ values were 947 ± 273 ng.ml'1.h and 868 ± 265 ng.ml'1.h (90% confidence intervals 0.99-1.21) for the test and the reference formulations, respectively.
Conclusion: The study has shown that the two formulations are bioequivalent with respect to the rate and extent of absorption of famotidine after a single oral administration of 40 mg famotidine in healthy volunteers.
Key Words: Famotidine, Bioavailability,
Bioequivalence.

References

  • Wanwimolruk S, Zoest AR, Wanwimolruk SZ, Hung CT. Sensitive high performance liquid chromatographic determination of famotidine in plasma: application of pharmacokinetic study. J Chromatography 1991 ;5 72:22 7-238.
  • Yeh KC- Chremos AH, Lin JH, et al. Single dose pharmacokinetics and bioavailabilty of famotidine in man: results of multicenter collaborative studies. Biopharm Drug Dispos 1987/8:549-560.
  • Hagita A, Manago M, Aoki S, et al. Pharmacokinetics and pharmacodynamics of famotidine in children with gastroduodenal ulcers. Ther Drug Monit 1994/16:444-449.
  • Kroemer H, Klotz U. Pharmacokinetics of famotidine in man. Int J Clin Pharmacol Ther Toxicol 1987/25:458-463.
  • liawai R, Yamada S, Rawamura S, Miwa T, Miwa PI. Metabolic fate of famotidine (YM-111 70), a new potent H2-recepor antagonist: absorption and
  • excretion in dogs and humans. Pharmacometrics 1984/27:73-77.
  • Vodopivec P, Rozjek F, Rarba R, Primozic S, Mrhar A. Modeling of famotidine pharmacokinetics. Acta Pharm 1993/43:83-86.
  • Echizen H, Ishizaki T. Clinical pharmacokinetics of famotidine. Clin Pharmacokinet 1991/21:178-194.
  • Wagner BR, DiFazio LT, Amory DW, et al. Famotidine pharmacokinetics in patients undergoing cardiac surgery. Drug Invest 1994/8:271-277.
  • Beak LC, Ganesh S, Jansen JB, Lamers CB. Does smoking influence the pharmacokinetics and pharmacodynamics of the fl2-rec.eptor antagonist famotidine? Br J Clin Pharmacol 1992:33:193-196.
  • Steinijans VW, Hauschke D, Schall R. International harmonization of regulatory requirements for average bioequivalence and current issues in individual bioequivalence. Drug Inf J 1995/29:1055-1062.
  • 1. Anderson S, Hauck WW. Consideration of individual bioequivalence. J Pharmacokin Biopharm ¡990/18:259-273.

Year 1999, Volume: 12 Issue: 2, 74 - 78, 03.12.2016

Ece İskender Serhan Tuğlular Zafer Gören Rezzan Aker Ahmet Akıcı Atila Karaalp Neslihan Aslan Mehmet Koç Filiz Onat Emel Akoğlu Kemal Berkman Şule Oktay

Abstract

References

  • Wanwimolruk S, Zoest AR, Wanwimolruk SZ, Hung CT. Sensitive high performance liquid chromatographic determination of famotidine in plasma: application of pharmacokinetic study. J Chromatography 1991 ;5 72:22 7-238.
  • Yeh KC- Chremos AH, Lin JH, et al. Single dose pharmacokinetics and bioavailabilty of famotidine in man: results of multicenter collaborative studies. Biopharm Drug Dispos 1987/8:549-560.
  • Hagita A, Manago M, Aoki S, et al. Pharmacokinetics and pharmacodynamics of famotidine in children with gastroduodenal ulcers. Ther Drug Monit 1994/16:444-449.
  • Kroemer H, Klotz U. Pharmacokinetics of famotidine in man. Int J Clin Pharmacol Ther Toxicol 1987/25:458-463.
  • liawai R, Yamada S, Rawamura S, Miwa T, Miwa PI. Metabolic fate of famotidine (YM-111 70), a new potent H2-recepor antagonist: absorption and
  • excretion in dogs and humans. Pharmacometrics 1984/27:73-77.
  • Vodopivec P, Rozjek F, Rarba R, Primozic S, Mrhar A. Modeling of famotidine pharmacokinetics. Acta Pharm 1993/43:83-86.
  • Echizen H, Ishizaki T. Clinical pharmacokinetics of famotidine. Clin Pharmacokinet 1991/21:178-194.
  • Wagner BR, DiFazio LT, Amory DW, et al. Famotidine pharmacokinetics in patients undergoing cardiac surgery. Drug Invest 1994/8:271-277.
  • Beak LC, Ganesh S, Jansen JB, Lamers CB. Does smoking influence the pharmacokinetics and pharmacodynamics of the fl2-rec.eptor antagonist famotidine? Br J Clin Pharmacol 1992:33:193-196.
  • Steinijans VW, Hauschke D, Schall R. International harmonization of regulatory requirements for average bioequivalence and current issues in individual bioequivalence. Drug Inf J 1995/29:1055-1062.
  • 1. Anderson S, Hauck WW. Consideration of individual bioequivalence. J Pharmacokin Biopharm ¡990/18:259-273.
There are 12 citations in total.

Details

Journal Section Original Research
Authors

Ece İskender This is me

Serhan Tuğlular This is me

Zafer Gören This is me

Rezzan Aker This is me

Ahmet Akıcı This is me

Atila Karaalp This is me

Neslihan Aslan This is me

Mehmet Koç This is me

Filiz Onat This is me

Emel Akoğlu This is me

Kemal Berkman This is me

Şule Oktay This is me

Publication Date December 3, 2016
Published in Issue Year 1999 Volume: 12 Issue: 2

Cite

APA İskender, E., Tuğlular, S., Gören, Z., Aker, R., et al. (2016). COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS. Marmara Medical Journal, 12(2), 74-78.
AMA İskender E, Tuğlular S, Gören Z, Aker R, Akıcı A, Karaalp A, Aslan N, Koç M, Onat F, Akoğlu E, Berkman K, Oktay Ş. COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS. Marmara Med J. June 2016;12(2):74-78.
Chicago İskender, Ece, Serhan Tuğlular, Zafer Gören, Rezzan Aker, Ahmet Akıcı, Atila Karaalp, Neslihan Aslan, Mehmet Koç, Filiz Onat, Emel Akoğlu, Kemal Berkman, and Şule Oktay. “COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS”. Marmara Medical Journal 12, no. 2 (June 2016): 74-78.
EndNote İskender E, Tuğlular S, Gören Z, Aker R, Akıcı A, Karaalp A, Aslan N, Koç M, Onat F, Akoğlu E, Berkman K, Oktay Ş (June 1, 2016) COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS. Marmara Medical Journal 12 2 74–78.
IEEE E. İskender, “COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS”, Marmara Med J, vol. 12, no. 2, pp. 74–78, 2016.
ISNAD İskender, Ece et al. “COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS”. Marmara Medical Journal 12/2 (June 2016), 74-78.
JAMA İskender E, Tuğlular S, Gören Z, Aker R, Akıcı A, Karaalp A, Aslan N, Koç M, Onat F, Akoğlu E, Berkman K, Oktay Ş. COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS. Marmara Med J. 2016;12:74–78.
MLA İskender, Ece et al. “COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS”. Marmara Medical Journal, vol. 12, no. 2, 2016, pp. 74-78.
Vancouver İskender E, Tuğlular S, Gören Z, Aker R, Akıcı A, Karaalp A, Aslan N, Koç M, Onat F, Akoğlu E, Berkman K, Oktay Ş. COMPARATIVE BIOAVAILABILITY OF TWO DIFFERENT TABLETS OF FAMOTIDINE IN TWENTY FOUR HEALTHY VOLUNTEERS. Marmara Med J. 2016;12(2):74-8.