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.
NCT06923956 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2025-04-11
Summary
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.
Conditions
- Hypercholesterolaemia
- Mixed Dyslipidaemia
- Cardiovascular Diseases
Interventions
- DRUG
-
Bempedoic Acid Film Coated Tablet
1 tablet of 180 mg Bempedoic Acid
- DRUG
-
Nilemdo® (Bempedoic Acid) Film-coated tablets
1 tablet of 180 mg Bempedoic Acid
Sponsors & Collaborators
-
Humanis Saglık Anonim Sirketi
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-04
- Primary Completion
- 2024-12-18
- Completion
- 2025-02-08
Countries
- India
Study Locations
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