Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT06923956
Phase
PHASE1
Status
Completed

Conditions

  • Cardiovascular Diseases
  • Hypercholesterolaemia
  • Mixed Dyslipidaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.

Key Dates

Start date
Dec 4, 2024
Status verified
Apr 2025
Primary completion
Dec 18, 2024
Completion
Feb 8, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Bempedoic Acid Film Coated Tablet
    Bempedoic Acid 180 mg Film Coated Tablet
  • Active Comparator: Nilemdo® (Bempedoic Acid) Film-coated tablets
    Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets

Primary Outcome Measure

Maximum measured plasma concentration over the time span specified (Cmax) [ Time Frame: 72.00 hours ]

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