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Pharmacokinetics clinical trials

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NCT ID: NCT05481385 Enrolling by invitation - Pharmacokinetics Clinical Trials

Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

Start date: July 15, 2022
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT05480787 Active, not recruiting - Anesthesia Clinical Trials

Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU

Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.

NCT ID: NCT05478278 Completed - Pharmacokinetics Clinical Trials

An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics

Start date: June 22, 2022
Phase: Phase 1
Study type: Interventional

This study is comprised of two parts. The purpose of the first part of this study is to evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization. The purpose of the second part of the study is to evaluate the effects of food on the pharmacokinetics of psilocybin.

NCT ID: NCT05469854 Recruiting - Pharmacokinetics Clinical Trials

A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate

Start date: July 13, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized study designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of 2 single ascending oral doses of linaprazan glurate. The study will explore the PK properties of linaprazan glurate and linaprazan as well as the cardiodynamic ECG effects, safety, and tolerability after the administration of single doses (300 mg, 600 mg, 200 mg and a final dose level of maximum 400 mg) of linaprazan glurate, using 25 mg base formulation (300 mg and 600 mg doses) and 25 mg and 100 mg HCl formulation (200 mg and final dose level of maximum 400 mg) oral tablets.

NCT ID: NCT05460065 Recruiting - Pharmacokinetics Clinical Trials

Single and Multiple Intravenous Administrations of Estetrol (E4) in Healthy Adult Volunteers

Start date: April 4, 2022
Phase: Phase 1
Study type: Interventional

The Sponsor intends to develop an intravenous (i.v.) formulation of E4 for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). E4 has not been administered intravenously to humans yet. This single-center, double-blind, placebo-controlled randomized study aims to evaluate the safety, tolerability, and PK of an i.v. E4 solution administered as single-dose or multiple dose to healthy adult volunteers.

NCT ID: NCT05452785 Completed - Pharmacokinetics Clinical Trials

A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects

Start date: May 7, 2022
Phase: Phase 1
Study type: Interventional

Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.

NCT ID: NCT05437094 Completed - Heart Failure Clinical Trials

Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740

Start date: June 27, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male and female subjects. Subjects will be admitted into the study site on Day -1 and will be confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.

NCT ID: NCT05436678 Completed - Pharmacokinetics Clinical Trials

A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject

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

This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions. The subjects will receive the test treatment in one of the study periods and the reference treatment in the other study period according to a two-sequence randomization schedule. Blood samples will be collected before the morning dose on Day 1, before the morning and evening dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until approximately 48 hours after the final dose on Day 7.

NCT ID: NCT05433896 Completed - Pharmacokinetics Clinical Trials

Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions

Start date: November 1, 2020
Phase: Phase 1
Study type: Interventional

In this open label, single-sequence study, subjects received one dose of XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation at the start of study on Day 1 and Day 6. Omeprazole 40 mg was administered on Day 2, 3, 4, 5 and 6. The study was conducted in two groups.

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.