View clinical trials related to Pharmacokinetics.
Filter by:This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216.
This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants.
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs. Humira® AC Pen [Reference Product]
Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults
The study compares three different formulations containing N-Acetyl Cysteine, with regards to acute absorption over a 24-hour period, following single ingestion. The formulations are traditional N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester, and a product containing a combination of N-Acetyl Cysteine Ethyl Ester, glycine, and two minerals with antioxidant potential (selenium and molybdenum) that might enhance the effect of N-Acetyl Cysteine Ethyl Ester. Subjects will report to the lab on three different occasions to consume the products, using a randomized cross-over design, and blood will be collected periodically (for the initial 8 hours and then again at 24 hours) per standard, routinely used pharmacokinetic /pharmacodynamic study protocols for evaluation of circulating glutathione concentrations. The hypothesis for this study is that the combination of N-Acetyl Cysteine Ethyl Ester + glycine will yield the greatest increase in glutathione, followed by N-Acetyl Cysteine Ethyl Ester, followed by N-Acetyl Cysteine. These findings will provide initial evidence specific to the bioavailability of these treatments following a single acute ingestion and may guide future recommendations regarding routine use.
The goal of this a clinical trial is to learn about the efficacy，safety and Pharmacokinetics of Hepenofovir Fumarate Tablets（HTS） in patients with CHB. The main questions it aims to answer are： 1. Evaluate the efficacy and safety of multiple doses of continuous administration of HTS in patients with chronic hepatitis B, and compare it with Tenofovir alafenamide Fumarate tablets（TAF）. 2. To evaluate the pharmacokinetic characteristics of HTS in patients with chronic hepatitis B after multiple oral administration. 3. To evaluate the pharmacodynamic changes of HTS in patients with chronic hepatitis B after multiple consecutive administrations, and compare it with TAF. Positive control drug：Tenofovir alafenamide Fumarate tablets（25mg/d） Test drug：Hepenofovir Fumarate Tablets（10mg/d、20mg/d、40mg/qod） Test process：This study was divided into 4 groups, with the specific list shown below. The initial plan was to include 12 subjects in each group, stratified by HBeAg status, with 4 subjects negative for HBeAg and 8 subjects positive for HBeAg. A total of 48 subjects were included in this trial, and they were randomly assigned to multiple doses at a ratio of 1:1:1:1. The dosing period was 24 weeks. However, after enrolling 37 subjects (29 positive for HBeAg and 8 negative for HBeAg), the protocol was adjusted (V4.0): the remaining 11 subjects would be included, all of whom were over 30 years old with ALT < ULN and met all the inclusion criteria but none of the exclusion criteria. The random assignment was: 7 subjects positive for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 2:2:2:1; and 4 subjects negative for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 1:1:1:1.
This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.
Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. Due to limited data availability, the goal of this clinical trial is to learn about safety, pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) of Kratom in adult recreational polydrug users with opioid experience.
This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B) and XS005 Sorafenib Tablet A,100 mg (Regimen C) formulation. It is planned to enroll 15 subjects who will receive single oral doses of investigational medicinal product (IMP) across 3 treatment periods.
In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool. In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.