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Pharmacokinetics clinical trials

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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: NCT05898672 Completed - Healthy Volunteers Clinical Trials

A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine Rosuvastatin

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

The purpose of this study is to learn about the effect of the study medicine (called nirmatrelvir/ritonavir) on the pharmacokinetics of the medicine rosuvastatin in healthy volunteers. Pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it. This study is seeking participants who: - are male and female participants who are overtly healthy - are 18 years of age or older - have a Body mass Index (BMI) of 16-32 kg/m2 and total body weight >50 kg (110 lb). All participants in this study will receive nirmatrelvir/ritonavir, a standard treatment for mild-to-moderate COVID-19. All participants will also receive rosuvastatin. Nirmatrelvir/ritonavir will be given by mouth at the study clinic 2 times a day. Rosuvastatin will be given by mouth at the study clinic once (as a single dose). We will compare participant experiences to help us determine the effect of nirmatrelvir/ritonavir on the pharmacokinetics of rosuvastatin. Participants will take part in this study for approximately 11 weeks. During this time, they will have 10 days at the study clinic and 1 follow-up phone call. Blood samples will be collected during participants' time at the study clinic.

NCT ID: NCT05873426 Completed - Pharmacokinetics Clinical Trials

Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China

Start date: March 25, 2023
Phase: Phase 1
Study type: Interventional

This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]ZSP1273 in healthy Chinese male participates, revealing the overall pharmacokinetic characteristics of ZSP1273.

NCT ID: NCT05856513 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment

Start date: June 15, 2023
Phase: Phase 1
Study type: Interventional

This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.

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: NCT05852340 Completed - Healthy Volunteers Clinical Trials

A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants

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

The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults. This study is seeking participants who are: - aged 18 or older; - male or female who are healthy as determined by medical assessment ; - Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg. The study will take up to 2.5 months, including the screening period. There will be 5 periods in total for this study. Participants will have to stay at the study clinic for at least 11 days. Participants will take Riltecitinib either as sprinkled in Soft Food or as Intact Blend-In Capsule. On day 1 of each period, participants will take Riltecitinib and have blood samples taken both before and afterwards. Participants will also answer questions for taste assessment purpose. A follow-up phone call will be made at 28 to 35 days after the last study period.

NCT ID: NCT05847218 Completed - Pharmacokinetics Clinical Trials

Phase 1 Clinical Trial of RHN-001 in Healthy Adult Volunteers

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

The goal of this clinical Trial is to assess the safety, tolerability and Pharmacokinetic profile of 750 mg single oral dose of RHN-001 and 1500 mg of RHN-001 administered orally in fasted and fed conditions in healthy adult 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