NCT07170852

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Bempedoic acid film coated tablet	1 tablet of 180 mg Bempedoic Acid
DRUG	Nilemdo® Film-coated tablets	1 tablet of 180 mg Bempedoic Acid

Timeline

• Start date: 2025-05-21
• Primary completion: 2025-06-16
• Completion: 2025-08-21
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: India