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

NCT07170852 | Completed Phase 1

• 1 other identifier: C1B05475
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Maximum measured plasma concentration (Cmax)

  To determine bioequivalence for bempedoic acid, the 90% confidence interval of the relative mean (geometric least squares mean) of the assay to the reference product for the Ln-transformed Pharmacokinetic parameters Cmax had to be between 80.00% and 125.00%.

  72 hours

• Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration (AUCt)

  The 90% confidence interval of the relative mean (Geometric least square mean) of test to reference product for Ln-transformed Pharmacokinetic parameters AUCt was to be within 80.00% to 125.00% for Bempedoic acid to establish bioequivalence.

  72 hours

Secondary Outcomes (4)

• Area under the plasma concentration versus time curve from zero to infinity (AUCi)

  72 hours

• Time of the maximum measured plasma concentration (Tmax)

  72 hours

• Elimination Rate Constant (Kel)

  72 hours

• Apparent terminal elimination half-life (tHalf)

  72 hours

Study Arms (2)

Bempedoic acid film coated tablet

EXPERIMENTAL

Bempedoic acid 180 mg film coated tablet

Drug: Bempedoic acid film coated tablet; Drug: Nilemdo® Film-coated tablets

Nilemdo® Film-coated tablets

ACTIVE COMPARATOR

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

Drug: Bempedoic acid film coated tablet; Drug: Nilemdo® Film-coated tablets

Interventions

Bempedoic acid film coated tablet DRUG

1 tablet of 180 mg Bempedoic Acid

Bempedoic acid film coated tablet; Nilemdo® Film-coated tablets

Nilemdo® Film-coated tablets DRUG

1 tablet of 180 mg Bempedoic Acid

Bempedoic acid film coated tablet; Nilemdo® Film-coated tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 55 years old, both inclusive
• Sex: Males and/or non-pregnant, non-lactating females
• Female of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They used an acceptable form of contraception.
• For female of childbearing potential, acceptable forms of contraception included the following:
• Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
• Barrier methods containing or used in conjunction with a spermicidal agent, or
• Surgical sterilization, or
• Practicing sexual abstinence throughout the course of the study.
• Females were not considered of childbearing potential if one of the following was reported and documented on the medical history:
• Postmenopausal with spontaneous amenorrhea for at least one year, or
• Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or
• Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• Total hysterectomy and an absence of bleeding for at least 3 months.
• BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI values were rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
• Non-smokers and non-tobacco user (i.e. who had no past history of smoking and tobacco consuming for at least one year prior to study).

You may not qualify if:

• History of allergic responses to Bempedoic acid or other related drugs and any of its formulation ingredients.
• Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
• Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• History or presence of bronchial asthma.
• Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
• A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://druginteractions.medicine.iu.edu/MainTable.aspx).
• History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (includes subtypes B \& C).
• A positive test result for HIV antibody.
• Subjects who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
• Subject who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
• History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
• Intolerance to venipuncture.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Cliantha Research Limited

Noida, 201301, India

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: May 21, 2025
• Primary Completion: June 16, 2025
• Study Completion: August 21, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)