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Pharmacokinetics clinical trials

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NCT ID: NCT00779259 Completed - Pharmacokinetics Clinical Trials

Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline

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

In a prior in vitro study using human hepatocytes quinine was shown to induce the activity of Cytochrome p450 CYP 1A2. The present study will evaluate the extent to which quinine sulfate-related induction of this enzyme effects the pharmacokinetics of theophylline, a sensitive probe drug for the activity of CYP 1A2. It will also evaluate the effect of single-dose theophylline on the pharmacokinetics of steady-state quinine sulfate.

NCT ID: NCT00767351 Completed - Pharmacokinetics Clinical Trials

Variation in Serum Levels of Metformin in Patients With Reduced Renal Function

Start date: October 2008
Phase:
Study type: Observational

Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases. In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated. The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes. The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.

NCT ID: NCT00752310 Completed - Pharmacokinetics Clinical Trials

TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet

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

The purpose of this study is to evaluate in healthy volunteers how much and how fast the new suspension compared to the commercial darunavir tablet, given in combination with low-dose ritonavir, are absorbed into the body (called the relative oral bioavailability).

NCT ID: NCT00749879 Completed - Pharmacokinetics Clinical Trials

Crossover Study of the Safety and PK Properties of Proellex®

Start date: August 11, 2008
Phase: Phase 1
Study type: Interventional

Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.

NCT ID: NCT00748046 Completed - Prostate Cancer Clinical Trials

Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton

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

The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).

NCT ID: NCT00747721 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

DEX PK
Start date: September 2008
Phase: Phase 1
Study type: Interventional

The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.

NCT ID: NCT00746499 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

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

Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and cervicovaginal samples will be taken most mornings around the AM dose. Two visits, ~14 hrs in length will be required on Day 1 and 7. The purpose of this study is to measure how much raltegravir is found in the genital tract after taking it orally.

NCT ID: NCT00741169 Completed - Hepatitis C Clinical Trials

TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.

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

The purpose of this study is to assess the interactions seen when somebody doses with TMC435350 and Rifampin (commercial form of antibiotic).

NCT ID: NCT00731562 Completed - Smoking Cessation Clinical Trials

An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation

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

1. To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions. 2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.

NCT ID: NCT00730145 Completed - Pharmacokinetics Clinical Trials

A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

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

1. Quantify how much PD-0332334 is removed from the blood with hemodialysis 2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments. 3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.