Safety and Pharmacokinetics

2

Review clinical trials related to Safety and Pharmacokinetics. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Optimizing PreTerm Infant Ampicillin Dosing

The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are: * Does short-course ampicillin provide high enough levels of ampicillin at 48 hours? * Is short-course ampicillin safe for preterm infants to receive? Preterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin. Participants will: * stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed) * have a blood sample collected around 48 hours from when they started ampicillin * have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner

Participants needed: 60
Trial details
Phase: Phase 1, Phase 2Age: 0-7Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: May 28, 2026Locations: 1
Eligibility criteria

Documented informed consent from parent/guardian [+3]

Infant on extracorporeal support (e.g., ECMO) [+6]

Status: Not yet recruiting

Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone, a Concentrate for Solution Preparation for Infusion.

A two-stage placebo-controlled open-label safety and pharmacokinetics study of the drug Fluorothiazinone, a concentrate for the preparation of an infusion solution, with participation of adult healthy volunteers. Stage 1 - single administration; dose escalation will be carried out in sequential groups after evaluation of side effects data on day 7. Stage 2 - course administration of the selected dose. Total number of healthy replacement volunteers: 5.

Participants needed: 70
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUpdated: Sep 22, 2025
Eligibility criteria

Written Informed Consent to participate in the Study. [+31]

Volunteer who does not meet the inclusion criteria and meets at least one exclus... [+5]