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Pharmacokinetics clinical trials

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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).

NCT ID: NCT01721070 Completed - Pharmacokinetics Clinical Trials

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

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

Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

NCT ID: NCT01692262 Completed - Pharmacokinetics, Clinical Trials

Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.

PYRUS
Start date: November 2012
Phase: Phase 1
Study type: Interventional

To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy, in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated in patients who have progressed after chemotherapy (Part A) and in patients who have progressed before receiving chemotherapy (Part B). Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off). Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients on a dose and schedule selected from Part A.

NCT ID: NCT01682408 Completed - Pharmacokinetics Clinical Trials

Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

PK Combination
Start date: September 2012
Phase: Phase 1
Study type: Interventional

Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets