Healthy volunteers Healthy volunteers
Conditions
Interventions
1. Study A
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A 35 mg modified release tablet of trimetazidine dihydrochloride will be taken with 240 ml drinking water at room temperature.
2. Study B
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calorie breakfast will be served at 30 minutes before drug administration. Subjects should take the meal completely within 30 minutes after serving.
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After meal serving for 30 minutes,
subjects will take a 35 mg modified release tablet of trimetazidine dihydrochloride with 240 ml drinking water at room temperature.
3. Study C
3.1 Steady state build-
up (During day 1 to 4 and day 8 to 11)
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During steady-
state build-
one tablet of trimetazidine dihydrochloride 35 mg modified release with 240 ml of drinking water will be administrated to subjects in the morning and evening for 4 days,
a total of 8 doses.
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The standard meal will be served 30 minutes before each drug administration. Subjects should take the meal completely within 30 minutes after serving.
3.2 Profiling day (Day 5 and 12)
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Subjects will fast overnight at least 10 h prior to the administration on profiling day
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The standard meal will be served 30 minutes before drug administration. Subjects should take the meal completely within 30 minutes after serving.
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subjects will take a 35 mg modified release tablet of trimetazidine dihydrochloride with 240 ml drinking water at room temperature.,1. Study A
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Sponsors
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trimetazidine concentration in plasma (single-dose study) 0.0 - 48.0 h AUC0-t, AUC0-inf, and Cmax ,Trimetazidine concentration in plasma (multiple-dose study) 0.0 - 12.0 h AUC(0-Ï„)ss, Cmax,ss, and CÏ„,ss | — |
Secondary
| Measure | Time frame |
|---|---|
| safety at the beginning , during and at the end of the trial. clinical and laboratory examinations | — |
Countries
Thailand
Contacts
Public ContactChuleegone Sornsuvit
Faculty of Pharmacy, Chiang Mai University
Outcome results
None listed