European Journal of Drug Metabolism and Pharmacokinetics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Pharmacokinetics of Oral Rebaudioside A in Patients with Type 2 Diabetes Mellitus and Its Effects on Glucose Homeostasis: A Placebo-Controlled Crossover Trial
ConclusionRebaudioside A is readily absorbed after oral administration and metabolized to steviol and steviol glucuronide. However, no effect on glucose nor insulin or C-peptide excursion was observed during the OGTT at the time of maximal metabolite concentrations. Thus, no antidiabetic properties of rebaudioside A could be observed in patients with T2DM after single oral use.Clinical Trial RegistrationRegistered on ClinicalTrials.gov (NCT03510624). (Source: European Journal of Drug Metabolism and Pharmacokinetics)
Source: European Journal of Drug Metabolism and Pharmacokinetics - September 3, 2022 Category: Drugs & Pharmacology Source Type: research

Phase 1 Study to Assess the Safety and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Subjects Without Cystic Fibrosis With Moderate Hepatic Impairment
ConclusionsA dose reduction of elexacaftor/tezacaftor/ivacaftor is warranted in people with moderate hepatic impairment. (Trial registry number 2018-002570-40; registered 2 July 2018.) (Source: European Journal of Drug Metabolism and Pharmacokinetics)
Source: European Journal of Drug Metabolism and Pharmacokinetics - August 29, 2022 Category: Drugs & Pharmacology Source Type: research

Results From Drug –Drug Interaction Studies In Vitro and In Vivo Investigating the Inhibitory Effect of Finerenone on the Drug Transporters BCRP, OATP1B1, and OATP1B3
ConclusionAdministration of finerenone 40 mg once daily confers no risk of clinically relevant drug –drug interactions with substrates of BCRP, OATP1B1, or OATP1B3. The potential for relevant inhibition of these transporters suggested by in vitro findings was not confirmed in vivo. (Source: European Journal of Drug Metabolism and Pharmacokinetics)
Source: European Journal of Drug Metabolism and Pharmacokinetics - August 27, 2022 Category: Drugs & Pharmacology Source Type: research

Interchangeability between Generic and Reference Products: Limits of Average Bioequivalence Methodology
AbstractMarketing authorisation of generic drugs is based on a demonstration of the “average” bioequivalence (ABE), with acceptance limits of 0.8–1.25 for the 90% confidence interval (CI) of the ratio (generic versus reference) of geometric means of exposure (whole blood, serum or plasma drug concentration). However, when interchangeability of reference by one generic is cons idered during treatment of a given patient, such methodology cannot guarantee the lack of therapeutic impact especially for drugs with narrow therapeutic index. This review article describes the basis and limits of ABE methodology, and the adapt...
Source: European Journal of Drug Metabolism and Pharmacokinetics - August 19, 2022 Category: Drugs & Pharmacology Source Type: research

Dual Inhibition of CYP3A4 by Voriconazole and Clarithromycin Influences Tacrolimus Pharmacokinetics: Case Series  Study
(Source: European Journal of Drug Metabolism and Pharmacokinetics)
Source: European Journal of Drug Metabolism and Pharmacokinetics - August 17, 2022 Category: Drugs & Pharmacology Source Type: research

Combined Semi-mechanistic Target-Mediated Drug Disposition and Pharmacokinetic –Pharmacodynamic Models of Alirocumab, PCSK9, and Low-Density Lipoprotein Cholesterol in a Pooled Analysis of Randomized Phase I/II/III Studies
ConclusionThe maximum effect of alirocumab is achieved when free PCSK9 concentration is close to zero, as seen mostly after 150  mg every 2 weeks (Q2W) or 300 mg every 4 weeks (Q4W), indicating that there would be no additional clinical benefit of increasing the dose higher than these recommended dosing regimens. (Source: European Journal of Drug Metabolism and Pharmacokinetics)
Source: European Journal of Drug Metabolism and Pharmacokinetics - August 16, 2022 Category: Drugs & Pharmacology Source Type: research

Tigecycline Soft Tissue Penetration in Obese and Non-obese Surgical Patients Determined by Using In  Vivo Microdialysis
ConclusionFollowing a single dose of tigecycline, concentrations in the ISF of subcutaneous adipose tissue are decreased in heavily obese subjects, calling for an increased loading dose.EU Clinical Trials Registration NumberEudraCT No. 2012-004383-22. (Source: European Journal of Drug Metabolism and Pharmacokinetics)
Source: European Journal of Drug Metabolism and Pharmacokinetics - August 9, 2022 Category: Drugs & Pharmacology Source Type: research