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Pharmacokinetics clinical trials

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NCT ID: NCT06427317 Recruiting - Pharmacokinetics Clinical Trials

Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

DATATDM
Start date: March 19, 2024
Phase:
Study type: Observational

The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.

NCT ID: NCT06426836 Recruiting - Pharmacokinetics Clinical Trials

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

PADECMO
Start date: August 19, 2016
Phase: N/A
Study type: Interventional

Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).

NCT ID: NCT06425757 Recruiting - Pharmacokinetics Clinical Trials

Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia

Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia

NCT ID: NCT06379958 Recruiting - Pharmacokinetics Clinical Trials

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Start date: April 8, 2024
Phase: Phase 1
Study type: Interventional

A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects.

NCT ID: NCT06360796 Recruiting - Pharmacokinetics Clinical Trials

Study of Pharmacokinetics and Metabolism on [(14)C]ADC189

Start date: November 24, 2023
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT06122454 Recruiting - Pharmacokinetics Clinical Trials

A Phase Ic/IIb Study to Evaluate the Efficacy,Safety and Pharmacokinetics of HST in Patients With CHB

HTS
Start date: November 10, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT05855018 Recruiting - Pharmacokinetics Clinical Trials

A Study of Atropine Sulfate in Healthy Chinese Volunteers

Start date: May 9, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.

NCT ID: NCT05801484 Recruiting - Critical Illness Clinical Trials

Pharmacokinetics and Pharmacodynamics of Linezolid Continuous and Intermittent Administration

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokinetic/pharmacodynamic (PK/PD) indices, the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit. Subject inclusion criteria: A minimum of 30 subjects in each group will be included in the study, in accordance with the study inclusion criteria: - patients hospitalized in the intensive care unit, - female or male sex, - age over 18 years, - linezolid is prescribed by the attending physician, in empirical or targeted treatment Exclusion criteria: Patients who have documented severe liver failure (Child-Pugh C score). Patients who refuse to sign the informed consent

NCT ID: NCT05775692 Recruiting - Infection Clinical Trials

Population Pharmacokinetics of Fluconazole in the Treatment of Neonatal Fungal Infectious Disease

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

This study is based on the hypothesis that the pharmacokinetics of fluconazole in newborns and children are different from adults. We aim to study the population pharmacokinetics of newborns and children receiving the fluconazole for treatment of infectious diseases. In this study, we will detect fluconazole concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, we also want to correlate use of fluconazole with treatment effectiveness and incidence of adverse effects in newborns and children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in newborns and children. It will also set the foundation for further studies to improve fluconazole therapies for newborns and children.

NCT ID: NCT05755503 Recruiting - Pharmacokinetics Clinical Trials

Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients

Start date: February 21, 2023
Phase:
Study type: Observational

Protein-bound uremic toxins (PBUTs) are important uremic toxins, represented by indoxyl sulfate (IS), derived from the fermentation of dietary proteins by gut bacteria. The purpose of this study was to study the changes of IS in maintenance hemodialysis patients, and to construct a metabolic kinetics model of IS clearance. The model was then used to estimate the clearance rate of indoxyl sulfate by hemoperage, and to verify the application value of the model. This study intends to collect a series of serum, dialysate and urine samples from maintenance hemodialysis patients receiving high-throughput dialysis or hemodialysis filtration, so as to clarify the variation rule of IS during various blood purification treatments. Furthermore, a three-compartment model of dialysis IS metabolism kinetics was constructed according to the IS clearance of dialysis and residual kidney, and the above model was verified internally and externally. Finally, the model's fit and predictive value were validated in a group of MHD patients treated with HP without residual kidney.