Epilepsy
Conditions
Interventions
Group I:Cycle 1: Study participants were admitted to the phase I clinical trial research center 1 day before dosing, and fasted for at least 10 hours before dosing. On the morning of the day of admini
Group II:Cycle 1: Study participants were admitted to the phase I clinical trial research center 1 day before dosing, and fasted for at least 10 hours before dosing. On the morning of the day of admin
Sponsors
The first peoples hospital of loudi
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > = 18 years old health study participants, both male and female; 2. The weight of male study participants >=50.0 kg, the weight of female study participants >=45.0 kg, and the body mass index (BMI) is between 18.5~30 kg/m^2 (including boundary values); 3. Study participants voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. (History taking) Any clinical serious disease or any other disease that can interfere with the trial results such as cardiovascular system, endocrine system, nervous, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities in the past or currently; (e.g. familial short-QT syndrome epilepsy, depression, psychosis, hepatic insufficiency, renal insufficiency, severe bleeding tendency, etc.); 2.(History) Past or current history of chronic or active gastrointestinal disease such as gastrointestinal perforation, gastrointest fistula, esophageal disease, gastritis, gastrointestinal ulcer, enteritis, gastroesophageal reflux, pancreatitis, active gastroestinal bleeding or history of gastrointestinal surgery, and investigator feels that it is still clinically significant at present; or a history of gastrointestinal symptoms (diarrhea constipation, nausea, vomiting, irregularity of defecation, or alternating diarrhea and constipation) within 7 days before the first use of the study drug, and the feels that it is not appropriate to participate in the trial; 3. (History taking) Those who have had any drug-related rash reaction in the past; 4.(History) those who drove a car or operated dangerous machinery during the trial; 5.(History) History of allergy to one or more substances or to any ingredient in this product; 6.(History taking) Subjects who have had or currently have visual impairment, vision disorders (excluding normal myopia), diplopia, etc., are considered unsuitable for the trial by the investigator; 7.(History) those who had surgery within 28 days before the first dose of the study drug or plan to undergo surgery during the trial; 8.(History) Those who have used any medications (including vaccination) or health products (including traditional Chinese medicine) within 14 days before the first use the study drug; 9.Used any clinical trial drug or was enrolled in any drug/medical device clinical trial within 3 months before the first administration of the study drug; 10. (History) Subjects who have donated blood or blood components within 3 months before the first dose of the study drug or had a transfusion or have lost more than 400 mL of blood within 3 months before the first dose of the study drug; 11.(History taking) Persons who cannot tolerate venipuncture and/or have a history of hemophobia, needle phobia; 12. (History) Use of oral contraceptive agents within 30 days prior to the first dose of study drug, or use of long-acting est or progestin-releasing depot injections or implants within 6 months prior to the first dose of study drug; 13. (History) Those who had unprotected sexual behavior within 14 days before the first use of the study drug (females), or who are pregnant or lactating; 14. (Screening) Participants who are unable to take one or more non-hormonal contraceptive measures throughout the trial, or who plan toceive or donate sperm/ovum within 6 months after the end of the trial, or their partner; 15. (History taking) Those with special dietary requirements who cannot comply with a unified diet; 16. (History) Difficulty in swallowing; 17.(History) Those who drank excessive amount of tea, coffee or caffeine-containing beverages (more than 8 cups, 1 cup = 20 mL) on a daily basis within 3 months before the first use of the study drug; 18. (History) Those who have ingested or plan to ingest any food or beverage containing caffeine (e.g., coffee, black tea chocolate, etc.) or rich in xanthine compone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-72h; | — |
Countries
China
Contacts
Public ContactLiang Haiqiu
The First People's Hospital of Loudi City
Outcome results
None listed