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Official websites use. Share sensitive information only on official, secure websites. Correspondence: Minou van Seyen Minou. VEL exposure was reduced by VEL is a lipophilic weak base log D 6. Their median range age was 38 years 22—55 years and median range body mass index was Subjects were in normal health based on medical history, physical examination, vital signs, and biochemical and hematology data. No poor metabolizers and ultrarapid metabolizers were identified. One subject missed the intake of one omeprazole tablet in the intervention I arm. This deviation did not lead to exclusion of the study participant, because intake of omeprazole at the pharmacokinetic PK sampling day was observed by the trial nurse and investigator. In addition, the PK curve in this intervention arm was representative for the group. OME, omeprazole. Figure 2 demonstrates VEL exposure of the individual subjects for all regimens. Each line represents an individual subject. No serious adverse events AEs were reported during the trial. There were no clinically significant laboratory and physical abnormalities during the study. Safety and tolerability of VEL following the administration of multiple doses up to mg once daily 4. This might indicate that the effect of omeprazole on VEL exposure is less pronounced in subjects with increased omeprazole metabolism. Because the pH of gastrointestinal fluids was not measured in our study, it is unknown whether a difference in acidity could explain the differences in exposure between subjects in our trial. Earlier research of Walravens et al. Despite the lack of a significant effect on gastric pH, intake of an acid beverage significantly improved the solubility and absorption of the weak base posaconazole. The invasive nature of obtaining gastrointestinal fluid, which was not the primary objective of our study, withheld us to include this procedure in our study. However, we chose simultaneous administration because this method of administration is considered to be the most patientfriendly and most probably mimics the real life situation. The minimal VEL exposure in patients has not yet been established. Whether all patients are able to follow these recommendations is unknown, and this may affect results. Therefore, any negative effect on VEL exposure should be prevented to circumvent the risk of viral relapse. Solubility of VEL decreases strongly as the pH increases 3. As shown in Table S3 , the pH of acid beverages can differ between brands e. If patients must continue PPI treatment, the use of an acid beverage offers a simple solution to overcome a DDI in case standard solutions are not sufficient. However, individual considerations are recommended for patients with a risk for increased VEL exposure i. Subjects randomly received the reference and intervention treatments, with a washout period of 7 days. In between study days, subjects took omeprazole at home, and adherence was assessed as follows: i tablets were counted by the trial nurses, and ii subjects were instructed to record the time of medication intake and any AE in a diary. Power calculation was performed by using a mixed linear model with fixed factors period and treatment. Blood samples were stored in a refrigerator and centrifuged 5 minutes at 1, g within 2 hours. Genotyping was conducted by the laboratory of the department of Human Genetics of the Radboud University Medical Center. A noncompartmental analysis in WinNonlin version 8. Safety and tolerability were assessed during the study based on AE monitoring, physical examinations, and laboratory tests. The study was conducted in accordance with Good Clinical Practice, International Committee on Harmonization guidelines, and the Declaration of Helsinki and has been registered at ClinicalTrials. All participants signed informed consent forms before screening evaluations. Medication for this trial was donated by Gilead; the trial was sponsored by Radboud University Medical Center. All other authors declared no competing interests for this work. Table S1. Table S2. Adverse events during study period and relation to study medication or procedure. Table S3. The authors thank the volunteers for their participation in this study. This section collects any data citations, data availability statements, or supplementary materials included in this article. As a library, NLM provides access to scientific literature. Clin Pharmacol Ther. Find articles by Minou van Seyen. Find articles by Angela Colbers. Find articles by Evertine J Abbink. Find articles by Joost PH Drenth. Find articles by David M Burger. Open in a new tab. Click here for additional data file. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. T max hour a.

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