Pharmacokinetics and Pharmacodynamics

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Review clinical trials related to Pharmacokinetics and Pharmacodynamics. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia

The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia. The main questions it aims to answer are: Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing? Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability? Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time. Participants will: * Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen. * Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor. * Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).

Participants needed: 68
Trial details
Phase: Phase 4Age: 19-79Biological sex: AllType: InterventionalSponsor: Seoul National University HospitalUpdated: Sep 29, 2026Locations: 1
Eligibility criteria

Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to...

Emergency surgery [+9]

Status: Recruiting

Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity

This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity. The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing. The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.

Participants needed: 48
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: The United Bio-Technology (Hengqin) Co., Ltd.Updated: Aug 25, 2026Locations: 1
Eligibility criteria

Participants with overweight or obesity, aged 18-45 years inclusive; Cohort 1 in... [+3]

Known hypersensitivity or intolerance to investigational product or its excipien... [+33]

Status: Recruiting

Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis

Participants needed: 60
Trial details
Age: 2-18Biological sex: AllType: ObservationalSponsor: Children's Hospital of Fudan UniversityUpdated: May 29, 2025Locations: 1
Eligibility criteria

Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Ka... [+2]

Active bleeding or bleeding risk contraindicating anticoagulant therapy [+2]