Bioequivalence Study of Trimetazidine Dihydrochloride 35 mg Modified Release Tablets in Healthy Volunteers

Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University0 个研究点目标入组 69 人开始时间: 2019年7月3日最近更新: 2024年8月19日

试验速览

暂无简介。

•1) Male and female subjects aged between 18-45 years
•2) Body Mass Index (BMI) between 18.5-25.0 kg/m2 and body weight not less than 45 kg
•3) Healthy subjects based on medical history and physical examination
•4) Normal or not clinically significant abnormal of clinical laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), Aspartate transaminase (AST), Alanine transaminase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count, and urinalysis.
•5) Clinical laboratory result of hepatitis B is negative
•6) No clinically significant findings in vital sign measurement
•7) Nonsmoker or stop smoking for at least 6 months
•8) Females who participate in this study are:
•8.1) Nonpregnant female (negative result for pregnancy test)
•8.2) With childbearing potential, whom must commit to use
•acceptable non-hormonal contraceptive method of birth
•control for at least 2 weeks before and during the study
•as judged by the clinical investigators, such as condoms,
•non-hormonal intrauterine device (IUD), or willing to
•remain abstinence (not engage in sexual intercourse)
•8.3)Not currently breast feeding
•9) Subjects are able, willing, and likely to comply with study procedures and restrictions.

•1) Subjects with a history of allergy to trimetazidine or related structure of trimetazidine or other components in the formulation.
•2) Subjects with currently or history of alcohol addiction or drug abuse.
•3) Subjects with currently or history of severe asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, arrhythmia, hepatic, renal, endocrine, cardiovascular diseases, parkinson disease or any other conditions that may affect bioavailability of the medication studied or safety of the subjects.
•4) Subjects who use any medications including vitamins, herbal products, and dietary supplement, within 14 days before and during the study.
•5) Subjects who are unable to refrain from consumption of orange, pomelo, grapefruit within 7 days before and during the study.
•6) Subjects who are unable to refrain from caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before and during the study.
•7) Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates).
•8) Subjects with positive alcohol breath test.
•9) Subjects with a history of blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study.
•10) Subjects who participate in other clinical trials within 90 days before the initiation of the study.

发起方

Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University