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Pharmacokinetics clinical trials

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NCT ID: NCT00621699 Completed - Clinical trials for Hypercholesterolemia

Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects

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

The purpose of this study is to confirm a significant influence of ezetimibe and tacrolimus on each others pharmacokinetics

NCT ID: NCT00621101 Completed - Clinical trials for Hypercholesterolemia

Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects

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

The purpose of this study is to confirm a significant influence of ezetimibe and sirolimus on each others pharmacokinetics

NCT ID: NCT00616252 Completed - Pharmacokinetics Clinical Trials

Antiretroviral Drug Levels During and After Pregnancy

Start date: February 2008
Phase: N/A
Study type: Observational

In HIV-infected women, the use of combination therapy with antiretrovirals (ARV) in pregnancy prevents HIV related morbidity and mortality and prevents mother-to-child transmission of the HIV virus. Specifically, suppression of the virus to an undetectable level is important during the delivery of the baby to minimize potential HIV exposure. In Sub-Saharan Africa, the use of ARV combinations containing nevirapine is the cornerstone of current HIV therapy, due to an affordable cost, availability in a fixed dose combination pill, and generic availability. Maintaining the efficacy and preventing development of resistance against this agent by the HIV virus is imperative, as second line therapies are often more difficult to obtain, are more expensive, and present more challenges in drug storage in clinics and in the community. Pregnancy adds another dimension to the challenge of treating women with HIV, as the physiologic and metabolic changes can affect levels of antiretroviral agents in the body. Though these changes are known to exist, few trials have evaluated the effect of these factors on the pharmacokinetics of antiretroviral agents and their impact has yet to be demonstrated. We wish to evaluate if the physiologic changes that occur during pregnancy impact the levels of stavudine, lamivudine, and nevirapine compared to those of a non-pregnant, HIV-infected Ugandan female. These data are imperative to ensure adequate suppression of the HIV virus throughout pregnancy.

NCT ID: NCT00614029 Completed - Pharmacokinetics Clinical Trials

A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System

Start date: December 2006
Phase: Phase 1
Study type: Interventional

A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.

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: NCT00520104 Active, not recruiting - Pharmacokinetics Clinical Trials

Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

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

This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.