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The effect of food on ritonavir bioavailability following administration of ritonavir 100 mg film-coated tablet in healthy adult subjects

Purpose of the study

A new 100 mg tablet formulation of ritonavir has been developed that would not require refrigeration. This study compared the single-dose bioavailability of the final ritonavir 100 mg tablet formulation following a moderate-fat or high-fat meal relative to that under fasting conditions.

Methods

This was a single-dose, open-label, 3-period crossover study with a randomized, crossover design. Healthy male and female subjects (n = 27) participated in the study. Serial blood samples were collected for 36 hours after each dose. Ritonavir AUC from time 0 to the last measurable concentration (AUCt) and from time 0 to infinity (AUCinf), maximum plasma concentration (Cmax), and time of Cmax (Tmax) were determined using noncompartmental methods. The bioavailability of the tablet following a meal relative to the fasting condition was assessed by the two one-sided tests procedure using 90% confidence intervals (CI). Safety was assessed throughout the study.

Summary of results

Table 1 presents the food effect results of the ritonavir pharmacokinetic parameters following administration of the ritonavir tablet.

Table 1

Ritonavir Cmax and AUC were approximately 20–24% lower when dosed following a meal compared to administration under fasting conditions. The slight difference in Tmax is consistent with delayed gastric emptying following a meal. Overall, the tablet formulation was generally safe and well tolerated.

Conclusion

Overall, ritonavir pharmacokinetics after administration of the tablet are slightly affected by meal content (with moderate or high fat).

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Ng, J., Klein, C., Chui, Y. et al. The effect of food on ritonavir bioavailability following administration of ritonavir 100 mg film-coated tablet in healthy adult subjects. JIAS 11, P247 (2008). https://doi.org/10.1186/1758-2652-11-S1-P247

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-P247

Keywords

  • Gastric Emptying
  • Ritonavir
  • Fasting Condition
  • Maximum Plasma Concentration
  • Tablet Formulation