A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally

Part of paid clinical trials in San Antonio, Texas.

Sponsor
SK Life Science, Inc.
Study ID
NCT05572255
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg tablet via NG tube of cenobamate. All treatments will be administered under fasting conditions.

Key Dates

Start date
Sep 27, 2022
Status verified
Sep 2024
Primary completion
Jan 28, 2023
Completion
Jan 28, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A (Reference)
    An intact 200 mg cenobamate tablet administered orally.
  • Experimental: Treatment B (Test 1)
    A crushed 200 mg cenobamate tablet in suspension administrated orally.
  • Experimental: Treatment C (Test 2)
    A crushed 200 mg cenobamate tablet in suspension administered via an NG tube

Primary Outcome Measure

Cmax [ Time Frame: up to 38 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Worldwide Clinical TrialsSan AntonioTexas78217-

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