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Pharmacokinetics clinical trials

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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.

NCT ID: NCT01420211 Completed - Pharmacokinetics Clinical Trials

Influence of the OATP1B1 and OATP1B3 Genotype on the Hepatic Uptake of Primovist®

Start date: October 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the study is to assess the hepatic uptake of Primovist® after intravenous administration of 25 µmol/kg body weight in 56 healthy volunteers and in 60 patients with a liver disease in dependence on the OATP1B1- and OATP1B3-genotype.

NCT ID: NCT01415102 Completed - Pharmacokinetics Clinical Trials

A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.

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

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.

NCT ID: NCT01404598 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male

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

This study will be performed in 2 parts conducted in parallel: Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen 500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of nitrates (metabolite of naproxcinod) present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for 7 days or naproxen 500 mg bid for 7 days as a reference. Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod 3000 mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the transformation of the naproxcinod, after oral administration of a single supratherapeutic dose of 3000 mg.