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Pharmacokinetics clinical trials

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NCT ID: NCT01569828 Completed - Healthy Volunteer Clinical Trials

Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function

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

An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function

NCT ID: NCT01568281 Completed - Pharmacokinetics Clinical Trials

Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects

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

This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.

NCT ID: NCT01549639 Completed - Pharmacokinetics Clinical Trials

Blood Propofol Measurement During Anaesthesia Using Propofol Target Controlled Infusion

Start date: January 2012
Phase: N/A
Study type: Observational

Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and the operating room. The pharmacokinetics of propofol are difficult to predict in patients not conforming to the norms in which the original pharmacokinetic research was based. Such patients, including the critically ill, and morbidly obese, are increasingly being encountered. The investigators group have been involved in the development of a device which can measure blood propofol concentrations, and hope for this to be available to use in the operating room in a clinically useful timeframe in the future. Data will be collected on patients undergoing propofol based general anaesthesia. The Marsh target controlled algorithm in effect site mode (commonly used by anaesthetists) will be assessed for accuracy using the propofol monitor. A new proportional correction method will be developed using this data, designed to enable recalibration of the TCI algorithm in near real time in order to achieve a more accurate estimated propofol concentration in these identified patient groups. The research will investigate the effectiveness of a correction of estimated propofol levels based on a one off measurement early on in the anaesthetic, and will take subsequent samples to measure propofol levels without modifying the TCI algorithm. Additionally, data on anaesthetist choice of TCI model, and method of administration in this relatively unselected group of patients will be analysed.

NCT ID: NCT01501747 Completed - Pharmacokinetics Clinical Trials

The Placebo Effect May Involve Modulating Drug Bioavailability

Start date: February 2012
Phase: N/A
Study type: Interventional

The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their interaction. Current interpretation of clinical trials (the gold standard of evidence-based-medicine) assumes no interaction, and the mechanism(s) underlying such interaction have not been fully explored. One possibility is that the placebo effect may modulate drug bioavailability. Using caffeine as a model drug, we have recently shown that the placebo effect of caffeine ingestion prolongs caffeine half life. Due to the novelty of this finding and its important clinical practice and clinical research implications, it needs to be confirmed in another set of subjects and extended to additional drugs. The results of the study are expected to further our understanding of the mechanism of action of a widely used medical intervention, i.e., placebo. The results will be important for both clinical practice and clinical research.

NCT ID: NCT01496443 Completed - Pharmacokinetics Clinical Trials

TAK-875 Glimepiride Drug-Interaction Study

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

The purpose of this study is to determine the pharmacokinetics and safety of TAK-875, once daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus (T2DM).

NCT ID: NCT01489696 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

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

The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.

NCT ID: NCT01478503 Completed - Healthy Subjects Clinical Trials

To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females

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

The study aimed to compare age and gender differences for increasing doses of mirabegron when given to healthy young and elderly males and healthy young and elderly females.

NCT ID: NCT01465646 Completed - Pharmacokinetics Clinical Trials

Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 100 μg/ 75 μg Tablets

Start date: June 2003
Phase: Phase 1
Study type: Interventional

The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.

NCT ID: NCT01465633 Completed - Pharmacokinetics Clinical Trials

Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets

Start date: August 2003
Phase: Phase 1
Study type: Interventional

The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.

NCT ID: NCT01464450 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants

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

The primary objective of this study is to learn about the relative bioavailability (the extent to which the drug becomes available to the body) and pharmacokinetics (blood levels) of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The safety and tolerability of rivaroxaban will also be assessed.