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Pharmacokinetics clinical trials

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NCT ID: NCT03519750 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers

Start date: November 1, 2018
Phase: Phase 1
Study type: Interventional

We will investigate the safety and pharmacokinetics of melatonin, when administered rectally, intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers. The volunteers will have melatonin administered over 5 days; intravenously, rectally, intravesically, vaginally and transdermally. The participants will be followed for 24-48 hours with blood samples and questions about adverse events. There will be a wash-out between each session of a minimum of 7 days.

NCT ID: NCT03484585 Completed - Pharmacokinetics Clinical Trials

Rogaratinib (BAY1163877) Human Mass Balance Study

Start date: April 6, 2018
Phase: Phase 1
Study type: Interventional

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution. For further clinical development, human mass balance data are required to elucidate the absorption, distribution, metabolism, and excretion (ADME) of rogaratinib.

NCT ID: NCT03480243 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil

Start date: March 27, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy study participants.

NCT ID: NCT03438981 Completed - Critical Illness Clinical Trials

Optimization of PK/PD Target Attainment for Ceftriaxone in Critically Ill Patients With Community-acquired Pneumonia.

Start date: January 2013
Phase:
Study type: Observational

WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset

NCT ID: NCT03410771 Completed - Pharmacokinetics Clinical Trials

Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients

Start date: October 1, 2015
Phase: N/A
Study type: Observational

Bioelectrical impedance analysis is studied as a bedside tool to estimate capillary leak in order to guide dosing of hydrophilic antimicrobials.

NCT ID: NCT03369340 Completed - Pharmacokinetics Clinical Trials

Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

Start date: November 7, 2017
Phase: N/A
Study type: Interventional

This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.

NCT ID: NCT03326986 Completed - Cancer Clinical Trials

Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)

Start date: November 10, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five treatment periods. Each treatment period is separated by a 7-day washout period. Upon review of the interim safety and preliminary PK data of human exposure to date, Protocol Amendment 3 includes a third panel of participants, Panel C, to assess the PK of higher doses of MK-7252 and to assess the food effect of MK-7252.

NCT ID: NCT03324061 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration

Start date: November 30, 2017
Phase: Phase 1
Study type: Interventional

Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.

NCT ID: NCT03309657 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid

Start date: February 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Ceftolozane/tazobactam is an emerging newly available antibiotic that has a broad spectrum of activity, and could be potentially useful in the management of central nervous system infections. However, data relating to penetration of ceftolozane/ tazobactam into the central nervous system, where a barrier against drug distribution exists (i.e. blood brain barrier), is currently limited. In critically ill patients this is all the more challenging as achieving adequate antibiotic concentrations even in blood is difficult. The aim of this study is to describe the concentrations achieved in the cerebrospinal fluid (i.e. bodily fluid found surrounding and inside of the brain) and blood after a single dose of ceftolozane/tazobactam administered in critically ill patients with an existing external ventricular drain (i.e. a device used in neurosurgery that relieves elevated intracranial pressure in the brain). It is planned that this information gained will help develop dosing strategies that will achieve target concentrations that will successfully treat central nervous system infections in the future.

NCT ID: NCT03198624 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects

HTL0018318
Start date: May 16, 2017
Phase: Phase 1
Study type: Interventional

This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.