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Comparative Bioavailability Study of Two Oral Omeprazole Formulations after Single and Repeated Administrations in Healthy Volunteers

  • Pharmacokinetics
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Abstract

Objective: Two oral enteric-coated pellet formulations of omeprazole, Pepticum® (test formulation) and Mopral® (reference), were administered to 24 healthy volunteers for 5 days at a daily dose of 20mg omeprazole in order to investigate the comparative bioavailability of the two formulations.

Results: The data obtained in this study demonstrated the bioequivalence of the two formulations. No statistical differences were observed for the area under the plasma concentration-time curve (AUC0-t), the parameter to which the inhibition of acid secretion induced by omeprazole is directly related. Differences observed in maximum plasma drug concentration (Cmax) at day 1 for both formulations were not statistically significant. At steady-state, the differences found in Cmax were associated with a p-value <0.05 with the 90% confidence interval lying between the acceptance range (70 to 140%). Regarding time to reach Cmax(tmax), p < 0.01 was found both after single and repeated doses. In both cases, Pepticum® showed a delay in reaching Cmaxcompared with Mopral®: 2.15 ± 1.11 vs 1.48 ± 0.52h (day 1) and 1.94 ± 0.66 vs 1.31 ± 0.75h (day 5).

Conclusion: This study confirmed the reported increases in AUC and Cmax after repeated administrations, the important intersubject variability and the excellent biological and clinical tolerability of both formulations.

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Authors and Affiliations

  1. Aster Clinical Research Center, Paris, France

    T. Duvauchelle

  2. Cephac Bioanalytical Research Center, Poitiers-Saint Benoist, France

    L. Millerioux, V. Gualano & E. Evene

  3. Laboratorios Andrómaco, Doctor Zamenhof, 36, 28027, Madrid, Spain

    A. Alcaide

Authors
  1. T. Duvauchelle
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  2. L. Millerioux
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  3. V. Gualano
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  4. E. Evene
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  5. A. Alcaide
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Duvauchelle, T., Millerioux, L., Gualano, V. et al. Comparative Bioavailability Study of Two Oral Omeprazole Formulations after Single and Repeated Administrations in Healthy Volunteers. Clin. Drug Investig. 16, 141–149 (1998). https://doi.org/10.2165/00044011-199816020-00007

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  • DOI: https://doi.org/10.2165/00044011-199816020-00007

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