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Pharmacodynamics clinical trials

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NCT ID: NCT03813875 Completed - Pharmacodynamics Clinical Trials

Modeling and Application of Triple Drug Response Surface Models

Start date: June 12, 2019
Phase:
Study type: Observational

Demand for anesthesiologists outside the operating rooms is increasing. Surgeons, radiologists, endoscopists and other interventionists are performing procedures with greater complexity, sometimes accompanied by greater pain and therefore require some sedation. This growing need place a pivotal role on careful handling the delivered drugs. Specifically, the investigators wish to know how different classes of drugs interact in order for us to titrate the effects more precisely. Early studies used isobolograms and concentration effect curves as their tools but these methods are limited and incapable of making continuous bedside monitoring. Researchers integrated these methodologies mathematically and developed response surface models. It's becoming a very convenient tool to assess drug interactions. Drug interactions are visualized with a three dimensional graph, or a surface. Users will only need the calculated drug concentrations and a predicted loss of response probability will be given after a model is built. The process of model construction is complex and time demanding process. Our team has successfully built a dual-drug model for midazolam and alfentanil and several works have been published in renowned anesthesia journals. Dual-drug models are simple but their use is very limited. The investigators often use more than two drugs during practice and a three-drug model will be a great leap to monitor clinical pharmacodynamics. The investigators will collect vital signs, anesthestic depth (BIS=bispectral index, analgesia nociception index (ANI)), drug dosing (propofol, midazolam and alfentanil), and the MOAA/S (modified observer's assessment/alertness score) scores in patient who are receive routine general anesthesia under laryngeal mask or sedation for TEE (transesophageal echocardiography) examinations. Patient's consent will be obtained prior to enrollment. These recordings will be pooled into computer program for model construction. A novel model in the field of anesthesia was chosen and modified. As pioneers in this field in Taiwan, the investigators plan to perform a series of analysis using a novel model the investigators have built to look into detail on how drugs interact with each other. A safety boundary to avoid excessive respiratory depression can be drawn by the model. The main goal is to provide sedation that gives precision, patient comfort, rapid return of consciousness and safety based on the triple-drug response surface model.

NCT ID: NCT03378284 Completed - Clinical trials for Healthy Male Volunteers

A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

Start date: December 10, 2017
Phase: Phase 1
Study type: Interventional

A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

NCT ID: NCT03070470 Completed - Pharmacokinetics Clinical Trials

CiPA Phase 1 ECG Biomarker Validation Study

Start date: March 14, 2017
Phase: Phase 1
Study type: Interventional

This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium channel encoded by the human ether-à-go-go-related gene (hERG) with approximately equipotent late sodium and/or calcium block ("balanced ion channel" drugs) do not cause J-Tpeakc prolongation and that drugs that predominantly block hERG without late sodium or L-type calcium current block ("predominant hERG" drugs) cause QTc prolongation.

NCT ID: NCT02532998 Completed - Healthy Subjects Clinical Trials

A Study to Assess the Pharmacodynamic Effect of Single Doses of AZD9977 in Healthy Male Subjects

Start date: September 2015
Phase: Phase 1
Study type: Interventional

This is a Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics of AZD9977 following Single-Dose administration to healthy male subjects

NCT ID: NCT02512575 Completed - Clinical trials for Rheumatoid Arthritis

A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.

Start date: November 18, 2015
Phase: Phase 1
Study type: Interventional

This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects. The objectives are to study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid receptor modulator (SGRM). The study will also assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high doses of AZD9567 and placebo.

NCT ID: NCT02308748 Completed - Pharmacokinetics Clinical Trials

Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block

Start date: May 2014
Phase: Phase 1
Study type: Interventional

The primary objective of this research study is to test the hypothesis that late sodium current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).

NCT ID: NCT02306915 Completed - Pharmacokinetics Clinical Trials

PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants

Start date: October 2014
Phase: Phase 1
Study type: Interventional

Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching. Every effort will be made to match Caucasian and Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to maintain balance between male and female participants within the cohorts. There will be no replacement of participants following randomization.

NCT ID: NCT02086903 Completed - Pharmacodynamics Clinical Trials

Clopidogrel And Ticagrelor in Healthy Subjects

Start date: February 2014
Phase: Phase 3
Study type: Interventional

To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.

NCT ID: NCT02085863 Completed - Pharmacokinetics Clinical Trials

A Phase I Study in Young Healthy Women to Investigate the Effects of Laquinimod on Standard Oral Contraceptive When Both Treatments Are Given Together

Start date: February 2014
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, double blind, placebo controlled, 2-way crossover drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive combination.

NCT ID: NCT02010632 Completed - Pharmacodynamics Clinical Trials

Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid metabolite between generic and reference clopidogrel products in Thai healthy volunteers