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

Korábbi kezelés

• 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.
• 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.
• 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.

Más betegség

• History of allergic responses to Bempedoic acid or other related drugs and any of its formulation ingredients.
• 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 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.
• History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
• 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.

Laborértékek

• 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)].
• 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.

Egyéb

• History or presence of bronchial asthma.
• Intolerance to venipuncture.
• Institutionalized volunteer.

• 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