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Pharmacokinetics clinical trials

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NCT ID: NCT06095895 Not yet recruiting - Pharmacokinetics Clinical Trials

Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

MISSION
Start date: November 15, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05964114 Not yet recruiting - Pharmacokinetics Clinical Trials

First Time Right of Vancomycin

Start date: October 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05949385 Not yet recruiting - Pharmacokinetics Clinical Trials

A Study to Assess the Effect of Itraconazole Capsules on the Pharmacokinetics of ZX-7101A Tablets in Healthy Adult Subjects in China

Start date: July 12, 2023
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the effect of Itraconazole on pharmacokinetics of ZX-7101 in healthy Chinese adult subjects after oral administration of ZX-7101A tablets. The secondary objective of the study is to evaluate the safety and tolerability of single dose of ZX-7101A orally in healthy subjects. Evaluate the effect of Itraconazole on pharmacokinetics of pre-drug ZX-7101A in healthy Chinese adult subjects after oral administration of ZX-7101A tablets.

NCT ID: NCT05931341 Not yet recruiting - Pharmacokinetics Clinical Trials

Pharmacokinetic Profile of Rosemary Extract Supplement

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

This study is a clinical trial to observe changes in biomarkers in the blood at pre- and post-supplementation of rosemary extract in healthy adults.

NCT ID: NCT05665478 Not yet recruiting - Pharmacokinetics Clinical Trials

Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

Start date: December 31, 2022
Phase: N/A
Study type: Interventional

1. Evaluating the differences in the efficacy and safety of meropenem optimal dosing regimen predicted by the PPK/PD model combined with MAPB method for patients with malignant hematological myelopathy accompanied by fever, as compared with the current conventional treatment regimen; 2. The visualization software of meropenem individualized medication was developed with the help of JAVA development language, J2EE framework and SQL Server database.

NCT ID: NCT05617651 Not yet recruiting - Pharmacokinetics Clinical Trials

Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T

Start date: November 30, 2024
Phase: Phase 1
Study type: Interventional

This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults

NCT ID: NCT05421312 Not yet recruiting - Pharmacokinetics Clinical Trials

Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip

CONCENTRATE
Start date: September 2022
Phase: Phase 4
Study type: Interventional

To prevent periprosthetic joint infection (PJI), optimal penetration of antibiotics into the joint-space is needed. In revision arthroplasty, the incidence of PJI is increased compared to primary arthroplasty. In this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. The concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; MIC-90) of microorganisms that frequently cause PJI.

NCT ID: NCT05381870 Not yet recruiting - Pharmacokinetics Clinical Trials

Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

Start date: May 26, 2022
Phase: Phase 1
Study type: Interventional

The fasting bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

NCT ID: NCT04672707 Not yet recruiting - Pharmacokinetics Clinical Trials

Study on the Pharmacokinetics of Bromine Hexane Hydrochloride Tablets in Healthy Adults

Start date: December 12, 2021
Phase: Phase 1
Study type: Interventional

This clinical study is about increasing the dosage of bromine hexane hydrochloride to safety volume and continue to give it frequently in the new crown virus treatment could improve the efficacy.

NCT ID: NCT04045171 Not yet recruiting - Pharmacokinetics Clinical Trials

Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

PISTONS
Start date: August 10, 2019
Phase:
Study type: Observational

This study will use a multi-center, prospective design, with a "Real World Study" model, to include 200 patients with nephrotic syndrome. based on the Population Pharmacokinetics (PPK) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the Pharmacokinetics/ Pharmacodynamics (PK/PD) relationship of Tacrolimus in patients with nephrotic syndrome, and develop an optimal medication regimen.