HypercholesterolaemiaPhase 1NCT07170852
Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets
A Phase 1 study testing Bempedoic acid film coated tablet and Nilemdo® Film-coated tablets in people with Hypercholesterolaemia, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Bempedoic acid film coated tablet and Nilemdo® Film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 21 May 2025to 21 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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).
- Able to communicate effectively with study personnel.
- Able to give written informed consent to participate in the study.
- All volunteers were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which included:
- A physical examination (clinical examination) with no clinically significant finding.
- Results within normal limits or clinically non-significant for the following tests
Who cannot join
- 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.
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- 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.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
- Institutionalized volunteer.
- Used any prescribed medications (including simvastatin and pravastatin) within 14 days prior to the first dose of study medication.
- Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- Used of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
- Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- Subject who had serum uric acid higher than the upper limit of normal range during screening.
- AST, ALT values are 1.1 times higher than the upper limit of normal range during screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic acid film coated tabletDrug
1 tablet of 180 mg Bempedoic Acid
Nilemdo® Film-coated tabletsDrug
1 tablet of 180 mg Bempedoic Acid
| Study group | Role | What they receive |
|---|---|---|
| Bempedoic acid film coated tablet | Experimental | Bempedoic acid 180 mg film coated tablet Receives: 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 Receives: Drug: Bempedoic acid film coated tablet; Drug: Nilemdo® Film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 72 hours
Secondary outcomes (4)
Area under the plasma concentration versus time curve from zero to infinity (AUCi)
Descriptive Statistics
Measured: 72 hours
Time of the maximum measured plasma concentration (Tmax)
Descriptive Statistics
Measured: 72 hours
Elimination Rate Constant (Kel)
Descriptive Statistics
Measured: 72 hours
Apparent terminal elimination half-life (tHalf)
Descriptive Statistics
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start21 May 2025
- Primary completion16 Jun 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170852
- Sponsor's protocol ID
- C1B05475
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07170852
- Acronym / sponsor ID
- C1B05475
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bempedoic acid film coated tablet | Experimental | Drug: Bempedoic acid film coated tablet, Drug: Nilemdo® Film-coated tabletsBempedoic acid 180 mg film coated tablet |
| Nilemdo® Film-coated tablets | Active comparator | Drug: Bempedoic acid film coated tablet, Drug: Nilemdo® Film-coated tabletsNilemdo® (Bempedoic Acid) 180 mg Film-coated tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempedoic acid film coated tablet1 tablet of 180 mg Bempedoic Acid | Drug | Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets |
| Nilemdo® Film-coated tablets1 tablet of 180 mg Bempedoic Acid | Drug | Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets |
Primary outcome
Maximum measured plasma concentration (Cmax)
Time frame: 72 hours
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%.
Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration (AUCt)
Time frame: 72 hours
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.
4 secondary outcomes
Area under the plasma concentration versus time curve from zero to infinity (AUCi)
Time frame: 72 hours
Time of the maximum measured plasma concentration (Tmax)
Time frame: 72 hours
Elimination Rate Constant (Kel)
Time frame: 72 hours
Apparent terminal elimination half-life (tHalf)
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bempedoic acid film coated tablet and Nilemdo® Film-coated tablets in people with Hypercholesterolaemia, run by Humanis Saglık Anonim Sirketi at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum measured plasma concentration (Cmax) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.