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The effects of pummelo juice on pharmacokinetics of sildenafil in healthy adult male Jordanian volunteers

  • Pharmacokinetics and Disposition
  • Published:
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Abstract

Purpose

The main purpose of this work was to investigate the effect of pummelo juice on the pharmacokinetics of sildenafil after oral administration.

Methods

This was a comparative, randomized, two-period, two-treatment, two-sequence, single dose, crossover study investigating the effect of pummelo juice on the pharmacokinetics of sildenafil citrate tablets (equivalent to 50 mg sildenafil) in healthy male participants under fasting conditions compared with water as a control. Six healthy normal adult males were administered 50 mg sildenafil with pummelo juice or water at two different periods in a crossover study.

Results

Study results showed that pummelo juice reduced the rate and extent of sildenafil bioavailability to around 60% [maximum plasma concentration (Cmax); from 212.44 ng/ml to 134.07 ng/ml, 90% confidence interval (90% CI) 44.70–89.11, and area under the plasma concentration time curve from zero to infinity (AUC∞); from 564.51 ng.hr/ml to 336.87 ng.hr/ml, 90% CI 39.17–90.92]. This interaction was opposite to that expected and is speculated to be due to either an effect on transporters or a physicochemical interaction between sildenafil and some components of the juice.

Conclusion

Patients should be advised not to drink pummelo juice before or immediately after taking sildenafil.

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Acknowledgements

The corresponding author thanks Pharsight Corporation for providing the University of Jordan with WinNonlin 5.2 as a PAL user.

Declaration of Competing Interest

None declared

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Authors and Affiliations

  1. Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, University of Jordan, Amman, Jordan

    Mutasim A. Al-Ghazawi & Salah M. AbuRuz

  2. Department of Chemistry, Faculty of Science, University of Jordan, Amman, Jordan

    Maha S. Tutunji

Authors
  1. Mutasim A. Al-Ghazawi
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  2. Maha S. Tutunji
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  3. Salah M. AbuRuz
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Correspondence to Mutasim A. Al-Ghazawi.

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Al-Ghazawi, M.A., Tutunji, M.S. & AbuRuz, S.M. The effects of pummelo juice on pharmacokinetics of sildenafil in healthy adult male Jordanian volunteers. Eur J Clin Pharmacol 66, 159–163 (2010). https://doi.org/10.1007/s00228-009-0738-0

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  • DOI: https://doi.org/10.1007/s00228-009-0738-0

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