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Pharmacokinetic clinical trials

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NCT ID: NCT06378125 Recruiting - Safety Issues Clinical Trials

Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes

Start date: December 19, 2022
Phase: Phase 1
Study type: Interventional

A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes.

NCT ID: NCT06344858 Recruiting - Analgesia Clinical Trials

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

Keta-ANI
Start date: April 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: NCT06126562 Completed - Pharmacokinetic Clinical Trials

A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects

Start date: October 31, 2023
Phase: Phase 1
Study type: Interventional

This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.

NCT ID: NCT05938608 Withdrawn - 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: NCT05258474 Completed - Safety Issues Clinical Trials

Safety and Pharmacokinetics of Oral Controlled-ileocolonic-release Nicotinamide (CICR-NAM)

Start date: December 4, 2020
Phase: Phase 1
Study type: Interventional

Double-blind, randomised, placebo-controlled phase I trial with single-ascending and multiple-ascending dose to evaluate safety and pharmacokinetics of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to immediate-release nicotinamide and placebo in healthy subjects and in patients with inflammatory bowel diseases.

NCT ID: NCT04959110 Completed - Pharmacokinetic Clinical Trials

Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT

Citrate PK
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Citrate has been proposed as anticoagulation of choice in continuous renal replacement therapy (CRRT). However, little is known about the pharmacokinetics (PKs) and metabolism of citrate in liver failure patients who require CRRT with regional citrate anticoagulation (RCA).

NCT ID: NCT04820049 Completed - Tolerance Clinical Trials

F573 Ia Clinical Trial

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

Tolerance and PK study of F573

NCT ID: NCT04735913 Active, not recruiting - Pharmacokinetic Clinical Trials

Effects of Metabolic Enzymes and Transporter Gene Polymorphisms on the Pharmacokinetics and Metabolism of Oral Abiraterone Acetate in Healthy Chinese Adults

Start date: May 5, 2020
Phase: Early Phase 1
Study type: Interventional

1. To explore the relationship between the changes of plasma concentration of abiraterone acetate after taken orally on fasting or postprandial and gene polymorphism. 2. Study of drug Metabolite profiling after oral administration of abiraterone acetate on fasting and postprandial in Chinese adults.

NCT ID: NCT04708795 Completed - Safety Clinical Trials

Clinical Trial on Pharmacokinetic and Tolerability of AP701

Start date: January 11, 2020
Phase: Phase 1
Study type: Interventional

This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.