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.

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Status: Not yet 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: Jun 30, 2026Locations: 1
Eligibility criteria

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

Emergency surgery [+9]

Status: Recruiting

Comparison of the Pharmacokinetics (PK)and Pharmacodynamics (PD)Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers

The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN® (test product) and NovoRapid® (reference product) in healthy male participants. The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 7 days between dosing. A total of 44 participants will be enrolled in this trial and randomized in a 1:1 ratio into two groups (A/B), stratified by race (Asian, non-Asian).

Participants needed: 44
Trial details
Age: 18-55Biological sex: MaleType: InterventionalSponsor: Zhuhai United Laboratories Co., Ltd.Updated: May 22, 2026Locations: 1
Eligibility criteria

Healthy male participants aged 18 to 55 years (inclusive). [+4]

History of specific allergies (e.g., asthma, urticaria, eczema), or those allerg... [+24]

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]