Cardiovascular disease
Conditions
Interventions
Sponsors
Guangzhou Panyu Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Volunteers have a thorough understanding of this experiment and voluntarily sign an informed consent form approved by the ethics committee before the experiment. 2) Healthy Chinese population aged = 18 years old, with an appropriate proportion. 3) Normal or abnormal vital signs, physical examination, laboratory examination, and electrocardiogram examination have no clinical significance. 4) Male volunteers should weigh no less than 50 kg, female volunteers should weigh no less than 45 kg, and their body mass index should be between 18.5-26 kg/m^2 (including boundary values). Body mass index=weight (kg)/square of height (m^2). 5) Volunteers are able to communicate effectively with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Individuals who have previously or are currently suffering from any clinically serious diseases, such as neurological/psychiatric, respiratory, cardiovascular, digestive, blood and lymphatic, endocrine, skeletal and muscular disorders, etc., and have been determined by the researchers to have an impact on this study. 2) Individuals who are unable to communicate or cooperate with medical staff due to neurological, mental illness, or language disorders. 3) Individuals with a history of allergies or known allergies to trimetazidine and related excipients (starch, mannitol, povidone K30, talcum powder, magnesium stearate), who have been determined by the researchers to be unsuitable for enrollment. 4) Laboratory tests (blood routine, urine routine, blood biochemistry, infection eight items, blood pregnancy) that have been determined by clinical doctors to be abnormal and clinically significant. 5) Those who have special dietary requirements (such as not eating milk, eggs, or butter) and cannot follow a unified dietary arrangement. 6) Participants in any drug clinical trial within 3 months prior to the trial. 7) Individuals who take over-the-counter drugs, health supplements, Chinese herbal medicine or traditional Chinese medicine within 2 weeks prior to the trial, or who take prescription drugs within 1 month and are deemed unsuitable for enrollment by the researcher. 8) Individuals who have consumed excessive amounts of tea, coffee, or caffeinated beverages for a long period of time (8 or more cups per day, 1 cup is approximately 250mL); Or within 48 hours before the experiment, consume any food rich in xanthine compounds (such as chocolate) and beverages (including tea, coffee, cola, etc.), grapefruit juice, etc 9) Individuals who have donated blood within 3 months prior to the experiment and have lost a total of 400mL or more of blood due to donation or other reasons within 6 months (excluding female menstrual bleeding); Or those who plan to donate blood or blood components during the trial period or within one month after the end of the trial. 10) Individuals who have used drugs (such as morphine, methamphetamine, ketamine, ecstasy (methamphetamine), marijuana (tetrahydrocannabidiol), etc.) or tested positive for drug screening within the first three months prior to the trial; 11) Alcohol abusers [drink more than 14 units of alcohol per week (1 unit containing 14g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine)]. 12) Those who smoke more than or equal to 5 cigarettes per day within the 3 months prior to the experiment, or those who smoke less than 5 cigarettes per day and cannot ban smoking throughout the entire experiment period. 13) Patients with difficulty in venous blood collection, or those with a history of dizziness or needle fainting. 14) Individuals who have not taken contraceptive measures during sexual activity within the two weeks prior to the experiment (only applicable to female volunteers); Or those who plan to become pregnant or have their partner become pregnant within 3 months after the trial period and the end of the trial, or those who donate sperm or eggs within 3 months after the trial period and the end of the trial. 15) Female volunteers who used oral contraceptives within 30 days prior to the experiment. 16) Positive blood pregnancy test. 17) Pregnant or lactating female volunteers. 18) Lactose intolerant individuals. 19)The researchers believe that other volunteers who are not s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactPeijian Liu
Guangzhou Panyu Central Hospital
Outcome results
None listed