Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT07170852
Phase
PHASE1
Status
Completed

Conditions

  • Hypercholesterolaemia

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
May 21, 2025
Status verified
Sep 2025
Primary completion
Jun 16, 2025
Completion
Aug 21, 2025

Study Design

Enrollment
32 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® Film-coated tablets
    Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets

Primary Outcome Measure

Maximum measured plasma concentration (Cmax) [ Time Frame: 72 hours ]

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