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TP-05, Fasted Group for Healthy Subjects
Study Summary
This trial tests how food affects a drug in healthy people, giving the drug either with food or on an empty stomach.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
Does the research encompass persons over fifty years of age?
"The age range for this clinical trial is 18 - 59 years, so any adult who meets that requirement can apply."
Could you elucidate the potential health hazards of TP-05, Fasted Group?
"Our experts at Power assessed TP-05, Fasted Group to be relatively safe with a score of 1. This is due to the fact that this clinical trial has only conducted one phase of testing and has limited evidence regarding safety or efficacy."
Is the research team currently seeking participants for this trial?
"The information on clinicaltrials.gov affirms that this medical experiment is currently recruiting participants, having been first posted to the website on January 19th 2023 and most recently updated February 8th 2023."
What is the upper limit of participants in this exploration?
"Absolutely, according to the clinicaltrials.gov website this research trial is currently recruiting volunteers. This initiative was first introduced on January 19th 2023 and most recently updated on February 8th 2023. A total of 36 individuals are needed for one medical facility's participation in the study."
What aims does this clinical experiment hope to accomplish?
"The primary end-point of this experiment, to be observed until Day 60, is the exposure and pharmacokinetics (PK) of lotilaner in whole blood. Secondary objectives include evaluating safety through clinically relevant changes from baseline chemistry laboratory tests, physical examinations, and vital signs."
What criteria must potential participants fulfill in order to qualify for this experiment?
"This trial requires 36 volunteers who are between 18 and 59 years old, have no underlying medical conditions, do not smoke or are ex-smokers, weigh a minimum of 50 kgs with BMI scores from 18.5 to 29.9 (inclusive), as well as adhere to contraceptive regulations in order to participate."
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