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Pharmacokinetics clinical trials

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NCT ID: NCT01187862 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.

NCT ID: NCT01181700 Completed - Pharmacokinetics Clinical Trials

A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.

NCT ID: NCT01167452 Completed - Obesity Clinical Trials

Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations

Start date: July 2010
Phase: Phase 4
Study type: Interventional

This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight. The entire cohort was analyzed for the study outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data analysis. All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you will receive in this study will be referred to as study medication within this informed consent form. This drug is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which belongs to a class of medication known as "sulfones" and is approved by the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.

NCT ID: NCT01163630 Completed - Pharmacokinetics Clinical Trials

Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg

Start date: June 2010
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.

NCT ID: NCT01158755 Completed - Pharmacokinetics Clinical Trials

Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last decade, partly due to the HIV epidemic. Without treatment, virtually all patients with TB meningitis will die. With the current treatment regimens, TBM is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors. Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. Representative data are lacking, but it is clear that TBM is a growing problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the late 90's compared to approximately 100 in recent years. There is very little evidence for the current treatment regimen for TBM, which dates back to the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of TBM. To determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with TBM in Indonesia.

NCT ID: NCT01124760 Completed - Pharmacokinetics Clinical Trials

Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

Start date: May 2010
Phase: Phase 1
Study type: Interventional

The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on the pharmacokinetics of AZD9742.

NCT ID: NCT01121926 Completed - Healthy Subjects Clinical Trials

A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State

Start date: January 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when administered three times daily, for one week. For this purpose, the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of each of the two formulations was compared.

NCT ID: NCT01118702 Completed - Pharmacokinetics Clinical Trials

A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers

Start date: May 2010
Phase: Phase 1
Study type: Interventional

This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24 hour period after they take this medication.

NCT ID: NCT01084278 Completed - Pharmacokinetics Clinical Trials

Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)

Start date: May 2010
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal function, in patients with mild, moderate or severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An additional objective of this study is to study the clearance of colchicine and its metabolites by hemodialysis. Secondary objectives include evaluation of the safety and tolerability of colchicine in the study population.

NCT ID: NCT01082146 Completed - Pharmacokinetics Clinical Trials

RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

Start date: August 2008
Phase: Phase 1
Study type: Interventional

This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state