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Pharmacokinetics clinical trials

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NCT ID: NCT02242006 Completed - Critical Illness Clinical Trials

Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)

Start date: October 2014
Phase:
Study type: Observational

Severe acute kidney injury (AKI) is a common complication of critical illness affecting almost half of all patients with septic shock. Extracorporeal renal replacement therapy is a cornerstone in the management of AKI in these patients. Options for renal replacement therapy include continuous renal replacement (CRRT) therapy, intermittent dialysis (IHD) or a hybrid form of the two called sustained low efficiency dialysis (SLED). Globally there is a push to switch from traditional CRRT to SLED. Although there are resource and financial comparative benefits to SLED there is almost no literature describing how to dose antimicrobials (or other drugs for that matter). It appears that drug clearance on SLED may be more efficient than CRRT but not as efficient as IHD making extrapolation from these bodies of literature inappropriate for SLED. The investigators are proposing to conduct the population pharmacokinetic studies for the three most commonly used antimicrobials in critically ill patients receiving SLED therapy (piperacillin-tazobactam, meropenem and vancomycin). Population pharmacokinetic modeling of these drugs will provide estimates and sources of variability around pharmacokinetic parameters that will subsequently be used for Monte Carlo simulation to determine the most appropriate dosing regimens to achieve therapeutic targets while minimizing the risk of toxicity.

NCT ID: NCT02233972 Completed - Pharmacokinetics Clinical Trials

A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam

Start date: August 2014
Phase: Phase 4
Study type: Interventional

This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.

NCT ID: NCT02217761 Enrolling by invitation - Pharmacokinetics Clinical Trials

Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Start date: March 2012
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the factors influencing pharmacokinetic and pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.

NCT ID: NCT02215941 Completed - Pharmacokinetics Clinical Trials

Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers

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

The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment.

NCT ID: NCT02209506 Terminated - Pharmacokinetics Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants

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

The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.

NCT ID: NCT02206204 Completed - Pharmacokinetics Clinical Trials

Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects. Moxifloxacin is included as a positive control.

NCT ID: NCT02205320 Recruiting - Pharmacokinetics Clinical Trials

A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers

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

This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.

NCT ID: NCT02191462 Completed - Pharmacokinetics Clinical Trials

A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects

14NBHC
Start date: July 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study in to analyse the way in which the body processes Niagen (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the dose.

NCT ID: NCT02175407 Completed - Healthy Subjects Clinical Trials

A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects

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

The purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in combination with itraconazole.

NCT ID: NCT02170038 Completed - Pharmacokinetics Clinical Trials

Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol

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

The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.