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Pharmacokinetic clinical trials

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NCT ID: NCT06344858 Not yet recruiting - Analgesia Clinical Trials

Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI

Keta-ANI
Start date: March 30, 2024
Phase:
Study type: Observational [Patient Registry]

Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose.

NCT ID: NCT05938608 Not yet recruiting - Healthy Clinical Trials

A Study to Assess the Availability of Oral Primaquine and Its Inert Metabolite, Carboxyprimaquine, in the Body

PQcPQ
Start date: March 2024
Phase: Phase 1
Study type: Interventional

An open-label pharmacokinetic study. This study will enroll 20 healthy adult subjects (10 males and 10 females aged 18-60 years) at the Clinical Therapeutics Unit or inpatient ward, Faculty of Tropical Medicine, Mahidol University, Thailand. The investigator propose to conduct a definitive bioavailability and pharmacokinetic study in healthy adult volunteers, both male and female, with normal CYP2D6 genotypes to assess oral primaquine bioavailability by the administration of intravenous and oral primaquine on different days and calculate the proportion of drug converted to its inactive metabolite, carboxyprimaquine, in order to estimate the proportion of its active metabolites. The intravenous injection of the known amount of carboxyprimaquine will allow the calculation of carboxyprimaquine's volume of distribution.

NCT ID: NCT05367011 Not yet recruiting - Intensive Care Unit Clinical Trials

Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU

Start date: September 1, 2022
Phase:
Study type: Observational

Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Pharmacokinetic therapeutic monitoring and dosage adjustments are recommended for large families of antibiotics such as glycopeptides and aminoglycosides for a long time, but to this day still insufficiently practiced. Concerning Beta-Lactamines this practice is recommended by french society of pharmacology and therapeutic (SFPT) and french society of anesthesiology and intensive care (SFAR) since 2018. The main goal of the POP-TDM-ICU study is to find the predictive factors of clinical therapeutic efficacy of antibiotic therapy in sepsis or septic shock in intensive care, among which the use of the dosage pharmacokinetics of antibiotic therapy (TDM = Therapeutic Drug Monitoring). This study is a non-interventional study. Patients bacterial samples already collected in standard care and additional plasma samples will be collected as part of a biological collection with the consent of the patient or family member.

NCT ID: NCT04326881 Not yet recruiting - Pharmacokinetic Clinical Trials

A Study to Compare Pharmacokinetic and Safety Profiles of Different Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

Start date: April 7, 2020
Phase: Phase 1
Study type: Interventional

This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314.