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Pharmacokinetics clinical trials

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NCT ID: NCT05569278 Completed - Pharmacokinetics Clinical Trials

Safety and Pharmacokinetics of GEH200486 in Healthy Volunteers

Start date: August 22, 2022
Phase: Phase 1
Study type: Interventional

This is a single center, prospective, dose escalation study (4 different dose levels) for a novel magnetic resonance imaging (MRI) contrast agent, in male and female healthy volunteers . The study is primarily designed to collect safety data. In addition, researchers want to learn more about how the novel contrast agent, GEH200486 circulates and is eliminated from the body (pharmacokinetics) after injection in healthy volunteers. Up to 24 healthy volunteers will be enrolled and will each receive a single administration of one of the 4 doses of GEH200486. Each healthy volunteer will stay at the clinical unit for the first 24 hours post injection and return for up to 3 follow-up visits with 1 additional follow-up phone call. Dose escalation from one dose group to the next dose group will be sequential and only be allowed if the clinical safety of all healthy volunteers from the tested dose group is acceptable, as assessed by an independent safety committee, members of GEHC team and the principal investigator.

NCT ID: NCT05539872 Completed - Pharmacokinetics Clinical Trials

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers

Start date: August 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.

NCT ID: NCT05527834 Completed - Pharmacokinetics Clinical Trials

Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Start date: September 13, 2022
Phase: Phase 1
Study type: Interventional

This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.

NCT ID: NCT05517616 Completed - Pharmacokinetics Clinical Trials

The Absorption, Metabolism and Excretion of [14C]APG-2575 in Healthy Subjects

Start date: September 14, 2022
Phase: Phase 1
Study type: Interventional

This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi [14C] APG-2575 to healthy subjects.

NCT ID: NCT05509543 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T

Start date: August 24, 2022
Phase: Phase 1
Study type: Interventional

This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults

NCT ID: NCT05503498 Completed - PHARMACOKINETICS Clinical Trials

Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

PKMF
Start date: January 1, 2021
Phase:
Study type: Observational

characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.

NCT ID: NCT05503147 Recruiting - Aging Clinical Trials

Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)

CanPan
Start date: March 24, 2022
Phase: Phase 1
Study type: Interventional

Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs. The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.

NCT ID: NCT05490095 Completed - Pharmacokinetics Clinical Trials

Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults

Start date: July 23, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics and safety of SVG101 (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral administration.

NCT ID: NCT05488678 Completed - Pharmacokinetics Clinical Trials

Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

Start date: October 12, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.

NCT ID: NCT05486598 Recruiting - Pharmacokinetics Clinical Trials

A Study of Diet Influence of AL8326 in Chinese Healthy Adult Subjects

Start date: June 21, 2022
Phase: Phase 1
Study type: Interventional

Main study objective: the pharmacokinetic effects of high-fat diet on AL8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects. Secondary study objectives: safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects