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Pharmacokinetics clinical trials

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NCT ID: NCT00572884 Completed - Pharmacokinetics Clinical Trials

Metabolism of the Insecticide Permethrin

Start date: February 2006
Phase: N/A
Study type: Interventional

Military personnel are exposed to the insecticide permethrin when using the DOD Insect Repellent System. A urinary metabolite of permethrin that is in high abundance and is relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a biomarker can prevent over-exposure. The objectives are to identify the most abundant human urinary metabolite following dermal exposure; to utilize this information to develop rapid laboratory-based and field portable methods to monitor the degree of an individual's exposure to permethrin.

NCT ID: NCT00556998 Completed - Pharmacokinetics Clinical Trials

A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents

Start date: June 2008
Phase: Phase 2
Study type: Interventional

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.

NCT ID: NCT00550485 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic and Pharmacodynamic Effects of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene

Start date: October 2007
Phase: N/A
Study type: Interventional

The ABCB1-gene product P-glycoprotein is an integral membrane protein that actively transports substrates out of the intracellular compartment. One of the major sites of its action is the blood-brain-barrier. It is highly expressed in brain capillary endothelial cells and involved in limiting the access of substrates such as antidepressants to the central nervous system. A single nucleotide polymorphism (SNP) of the ABCB1-gene was recently identified showing a different treatment response to antidepressant drugs depending on the genotype. Therefore, it is assumed that healthy subjects with different genotypes of that SNP will be associated with significantly different brain levels of the antidepressant escitalopram after 6 days of intake. Sleep recordings are a useful bio-marker for effects of antidepressants on the CNS. Selective serotonin reuptake inhibitors (e.g. escitalopram) cause a suppression of REM sleep and a stronger fragmentation of sleep compared to untreated subjects. Higher plasma levels of antidepressants affected the sleep to a greater extent than lower levels. In line with this finding, we suppose that sleep EEG recordings of healthy subjects with different genotypes of the above mentioned SNP will be differently affected after taking 6 days escitalopram. In addition, effects of drug intake on the gene expression in lymphocytes and metabolic changes will be assessed.

NCT ID: NCT00549666 Completed - Pharmacokinetics Clinical Trials

A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

OC-DDI
Start date: August 2007
Phase: Phase 1
Study type: Interventional

A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen

NCT ID: NCT00532012 Completed - Pharmacokinetics Clinical Trials

Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®

Start date: September 2007
Phase: Phase 1
Study type: Interventional

The drug that is under investigation during this study is RhuDex® and is expected to be used as an oral treatment for rheumatoid arthritis. Normal stomach juices contain acid and previous studies have shown that this acidity reduces the solubility and therefore the absorption of RhuDex®. Administering the alkaline buffer meglumine with RhuDex® has shown to increase the solubility of RhuDex® by decreasing the stomach acidity. The purposes of this study are to determine: - the optimum level of meglumine which is required to achieve the best uptake of RhuDex® from the stomach into the blood - to determine the concentration of RhuDex® in the blood in the presence of the optimum level of meglumine - to investigate further the safety and tolerability of RhuDex®. The study will be conducted in healthy male volunteers.

NCT ID: NCT00482963 Completed - HIV Infections Clinical Trials

A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication

Start date: May 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.

NCT ID: NCT00474019 Completed - Pharmacokinetics Clinical Trials

Phase 1 Pharmacokinetics of Intravenous Nexium in Children

Start date: October 2007
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.

NCT ID: NCT00176085 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH

Start date: October 2004
Phase: Phase 1
Study type: Observational

A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. In this study, however, the authors did not trace the above questions due to analytical and methodological deficits. Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals

NCT ID: NCT00176072 Completed - Pharmacokinetics Clinical Trials

BlueCQ Bioavailability

Start date: August 2004
Phase: Phase 1
Study type: Observational

Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations - and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood, plasma and urine. Intraindividual cross over open comparison in healthy male and female individuals (6:6) with different MB formulations in randomised order for the determination of the absolute bioavailability of MB (part 1), followed by an explorative randomised parallel group comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in combination with 1000 mg sustained release MB (3 males and 3 females) in the participants of study part 1 (part 2).

NCT ID: NCT00176033 Completed - Healthy Clinical Trials

Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra

Start date: January 2005
Phase: Phase 1
Study type: Observational

The aim of this study is to determine the pharmacokinetics of Kaletraâ„¢ (HIV protease inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the two protease inhibitors. The latter will be studied by comparing intracellular concentrations of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in healthy individuals. These effects will be studied after single dose (day 1), during steady state (day 3), and during chronic treatment (day 14).