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Pharmacokinetics clinical trials

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NCT ID: NCT01953848 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate How Tamsulosin (at 1 Dose) and Solifenacin (at 2 Different Doses) Are Taken up From the Intestine, Distributed Through the Body and Eliminated From the Body When Administered in Combination as a Single Tablet (Called EC905)

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

Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet frequently and often having a sudden urgent need to go to the toilet. Certain patients with an enlarged prostate have complaints that may benefit from a combination of tamsulosin and solifenacin. EC905 is a single tablet containing both tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and solifenacin are taken up from the intestine, distributed through the body and eventually eliminated from the body when taken as a single EC905 tablet.

NCT ID: NCT01952561 Completed - Pharmacokinetics Clinical Trials

Expanded Use PK of Dapivirine Vaginal Ring

Start date: November 2013
Phase: Phase 1
Study type: Interventional

Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.

NCT ID: NCT01913379 Completed - Healthy Subjects Clinical Trials

Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole

Start date: August 2011
Phase: Phase 1
Study type: Interventional

A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.

NCT ID: NCT01851473 Completed - Pharmacokinetics Clinical Trials

Interactions Between Intravenous Cocaine and Acetazolamide or Quinine

Start date: October 24, 2012
Phase: Phase 1
Study type: Interventional

Background: - Scientists are studying medications that may be useful in treating cocaine addiction. It is important in these studies to know whether study participants are always taking their medications as directed. This study will look at two chemicals to see if they can be used to determine whether participants are taking their medications as directed. Because acetazolamide and quinine can be measured in plasma and urine, they are good test subjects for this study. They will be given alone, and combined with intravenous cocaine. Objectives: - To see how they body handles acetazolamide and quinine alone, and when combined with cocaine. Eligibility: - Individuals between 18 and 50 years of age who have smoked or used IV cocaine for at least one year and at least three times per month during the three months prior to screening. Urine test positive for cocaine within the prior 6 months Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. - This study will involve a 12-day inpatient stay at the National Institutes of Health. - On days 1, 5, and 10, participants will receive a dose of cocaine. Blood, urine, breath, and saliva samples will be collected up to 18 times a day for up to about 24 hours. - On days 2, 3, 4, and 5, participants will receive acetazolamide. Regular blood samples will be collected on Day 4. - Day 6 is a wash-out day with no drugs or blood tests. - On days 7, 8, 9, and 10, participants will receive quinine. Regular blood samples will be collected on Day 9. - On day 11, blood, urine, breath, and saliva samples will be collected in the early morning. Participants will be able to leave later in the day.

NCT ID: NCT01820143 Completed - Healthy Clinical Trials

Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety

Start date: February 2005
Phase: Phase 1
Study type: Interventional

The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1) and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg, 20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days; and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets for 5 consecutive days.

NCT ID: NCT01815684 Completed - Healthy Subjects Clinical Trials

A Study to Assess the Safety, Tolerability and Effects of Single Ascending Doses of ASP3652 in Healthy Subjects

Start date: August 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and female subjects.

NCT ID: NCT01789528 Completed - Pharmacokinetics Clinical Trials

A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL on the intestinal flora of male and female healthy volunteers after multiple administrations over 7 days. An assessment of the effect on intestinal flora is an important aspect to understand for the safe clinical use of the investigational products and is expected by regulatory agencies.

NCT ID: NCT01786512 Completed - Pharmacokinetics Clinical Trials

COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure

COSMIC-HF
Start date: February 26, 2013
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.

NCT ID: NCT01736527 Completed - Pharmacokinetics Clinical Trials

Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

Start date: January 2013
Phase: Phase 1
Study type: Interventional

To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.

NCT ID: NCT01735240 Completed - Asthma, Clinical Trials

Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.

Start date: December 2012
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile when administered with ketoconazole. Subjects will be treated first with AZD5069 only followed by a washout period before starting with the combined treatment (both ketoconazole and AZD5069).