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Pharmacokinetics clinical trials

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NCT ID: NCT02956109 Completed - Pharmacokinetics Clinical Trials

Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers

Start date: November 16, 2016
Phase: Phase 1
Study type: Interventional

Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.

NCT ID: NCT02894385 Completed - Pharmacokinetics Clinical Trials

Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)

Start date: September 13, 2016
Phase: Phase 1
Study type: Interventional

Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).

NCT ID: NCT02820935 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects

Start date: July 2016
Phase: Phase 1
Study type: Interventional

This is a two-part study to be conducted at a single study site in the US. Both parts of the study may be conducted in parallel. A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.

NCT ID: NCT02802735 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

Start date: June 22, 2016
Phase: Phase 1
Study type: Interventional

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

NCT ID: NCT02790684 Completed - Pharmacokinetics Clinical Trials

A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive. The radiolabeled investigational medicinal product will be administered to 12 healthy male subjects in 2 cohorts of 6 subjects each.

NCT ID: NCT02790671 Completed - Pharmacokinetics Clinical Trials

A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy Subjects

Start date: May 2016
Phase: Phase 1
Study type: Interventional

Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.

NCT ID: NCT02755532 Completed - Pharmacokinetics Clinical Trials

Bupivacaine Pharmacokinetics in Ultrasound-guided Axillary Brachial Plexus Block.

Start date: January 2014
Phase: N/A
Study type: Interventional

Introduction: The risk of systemic toxicity when using bupivacaine is a persistent problem, making its pharmacokinetic study crucial to the safety of regional anesthesia (RA). Little evidence exists regarding the effect of different concentrations of this drug on peak plasma levels. The present study compares two bupivacaine concentrations to establish how the concentration and exchange area affect the peak plasma level of this drug during axillary brachial plexus block. Latency and postoperative analgesia periods were also compared. Methods: 32 patients were randomly assigned to two groups. In the 0.25% group, 10 ml of 0.25% bupivacaine was injected per nerve; in the 0.5% group, 5 ml of 0.5% bupivacaine was injected per nerve. Peripheral blood samples were collected every 15 min during the first hour and every 30 min during the second hour to establish serum level dosage. High-performance liquid chromatography coupled with mass spectrometry was used for the analysis.

NCT ID: NCT02673567 Completed - Pharmacokinetics Clinical Trials

To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125

Start date: March 31, 2016
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.

NCT ID: NCT02671097 Completed - Healthy Volunteers Clinical Trials

Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate

Start date: February 2016
Phase: Phase 1
Study type: Interventional

Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics. PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.

NCT ID: NCT02668367 Completed - Healthy Volunteers Clinical Trials

Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers

Start date: November 2015
Phase: Phase 1
Study type: Interventional

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.