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Treatment A (Reference) for Healthy Subjects
Study Summary
This trial is testing the relative bioavailability of a crushed 200 mg cenobamate tablet vs. an intact (whole) 200 mg tablet vs. a crushed 200 mg tablet via NG tube.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 222 Patients • NCT01397968Trial 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
What potential risks accompany the administration of Treatment C (Test 2)?
"Our team at Power has assessed the safety of Treatment C (Test 2) to be a mere 1 out of 3 due to the limited clinical data concerning its efficacy and security."
To which demographic is eligibility for this trial extended?
"This clinical trial is actively enrolling 24 individuals aged 18 to 50 who can demonstrate good health. Criteria for potential participants include the following: Male or female subjects of 18 to 50 years old (inclusively), literacy in order to read, understand and sign an informed consent form, BMI between 18.5-30.0 kg/m2, normal electrocardiogram results, blood pressure and heart rate readings., compliance with study protocols and ability to complete the trial as planned by investigators; females must have undergone a surgical sterilization procedure at least 6 months prior dosing or be postmenopausal with amenorrhea for 1 year before"
Is this research program currently open for recruitment?
"Affirmative. Published records on clinicaltrials.gov confirm that this research project, which originally went public on September 27th 2022, is actively recruiting participants. 24 individuals must be sourced from 1 medical site in order to complete the trial's requirements."
What is the aggregate count of participants in this medical trial?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial has openings for 24 participants, which was initially posted on September 27th 2022 and last updated October 6th 2022 at a single site."
What results are researchers expecting to glean from this investigation?
"SK Life Science, Inc., the study sponsor, has outlined that Cmax is the primary objective to be measured over a span of 38 days. Additionally, they will also assess safety and tolerability through vitals signs such as systolic and diastolic blood pressure readings, pulse rate measurements, respiration rates, body temperature checks and Columbia Suicide Severity Rating Scale scores. Lastly, adverse events (AEs) are another secondary outcome being tracked for this trial."
Does this research initiative encompass individuals who are younger than 65 years of age?
"This experiment adheres to the inclusion criteria of 18 as a minimum age and 50 as a maximum age for participation."
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