NCT07170852已完成1 期
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
Humanis Saglık Anonim Sirketi1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年5月21日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum measured plasma concentration (Cmax)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
Bempedoic acid film coated tablet
Experimental
Bempedoic acid 180 mg film coated tablet
干预措施: Bempedoic acid film coated tablet (Drug)
Bempedoic acid film coated tablet
Experimental
Bempedoic acid 180 mg film coated tablet
干预措施: Nilemdo® Film-coated tablets (Drug)
Nilemdo® Film-coated tablets
Active Comparator
Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets
干预措施: Bempedoic acid film coated tablet (Drug)
Nilemdo® Film-coated tablets
Active Comparator
Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets
干预措施: Nilemdo® Film-coated tablets (Drug)
结局指标
主要结局
Maximum measured plasma concentration (Cmax)
时间窗: 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)
时间窗: 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.
次要结局
- Elimination Rate Constant (Kel)(72 hours)
- Time of the maximum measured plasma concentration (Tmax)(72 hours)
- Area under the plasma concentration versus time curve from zero to infinity (AUCi)(72 hours)
- Apparent terminal elimination half-life (tHalf)(72 hours)
研究者
研究点 (1)
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