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Pharmacokinetics clinical trials

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NCT ID: NCT06095895 Not yet recruiting - Pharmacokinetics Clinical Trials

Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

MISSION
Start date: November 15, 2023
Phase:
Study type: Observational

This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.

NCT ID: NCT06072170 Completed - Pharmacokinetics Clinical Trials

Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience

Start date: September 12, 2023
Phase: Phase 1
Study type: Interventional

Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. Due to limited data availability, the goal of this clinical trial is to learn about safety, pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) of Kratom in adult recreational polydrug users with opioid experience.

NCT ID: NCT05967377 Completed - Pharmacokinetics Clinical Trials

Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects

Start date: November 16, 2018
Phase: Phase 1
Study type: Interventional

This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B) and XS005 Sorafenib Tablet A,100 mg (Regimen C) formulation. It is planned to enroll 15 subjects who will receive single oral doses of investigational medicinal product (IMP) across 3 treatment periods.

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.