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Pharmacokinetics clinical trials

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NCT ID: NCT00947349 Completed - Hepatitis C Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications. A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients

NCT ID: NCT00915746 Completed - Healthy Clinical Trials

A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers

Start date: November 2009
Phase: Phase 1
Study type: Interventional

This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of study/early withdrawal assessment phase.

NCT ID: NCT00915668 Withdrawn - Healthy Clinical Trials

A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Women

Start date: n/a
Phase: Phase 1
Study type: Interventional

The main purpose of this research study is to evaluate the effect of multiple doses of an investigational drug known as JNJ-31001074 on the single dose of combination oral contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who cannot bear children. This study will look at the safety, tolerability (how the drug makes you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in combination in healthy women.

NCT ID: NCT00915434 Completed - Healthy Clinical Trials

A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers

Start date: June 2009
Phase: Phase 1
Study type: Interventional

This is an open-label (both the physician and healthy volunteer know which treatment will be administered), single-dose, 4-period study to characterize the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and effect of food on the pharmacokinetics of JNJ-31001074. The study consists of three phases: a screening phase to determine eligibility, an open-label 4-period treatment phase and an end-of-study/early withdrawal assessment phase.

NCT ID: NCT00901290 Suspended - Pharmacokinetics Clinical Trials

Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive

NCT ID: NCT00868764 Completed - Pharmacokinetics Clinical Trials

An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron

Start date: April 2009
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.

NCT ID: NCT00867282 Completed - Pharmacokinetics Clinical Trials

A Study to Estimate the Time Course of PF-00241939 Concentration in the Blood Following Dosing by Oral Inhalation From Dry Powder Inhalers

B0871003
Start date: June 2009
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: NCT00863551 Completed - Overactive Bladder Clinical Trials

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Start date: April 2009
Phase: Phase 4
Study type: Interventional

This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.

NCT ID: NCT00856752 Completed - Pharmacokinetics Clinical Trials

Evaluation of the Pharmacokinetics of NRL972 Following Pre-Administration of Rifampicin and Cyclosporine

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

A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.

NCT ID: NCT00856570 Completed - Overactive Bladder Clinical Trials

A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects

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

This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.