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The effect of food on ritonavir bioavailability following administration of ritonavir 100 mg film-coated tablet in healthy adult subjects
Journal of the International AIDS Society volume 11, Article number: P247 (2008)
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.
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.
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.
Overall, ritonavir pharmacokinetics after administration of the tablet are slightly affected by meal content (with moderate or high fat).
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Cite this article
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
- Gastric Emptying
- Fasting Condition
- Maximum Plasma Concentration
- Tablet Formulation