Partial seizure of epilepsy
Conditions
Interventions
Group A:Fed condition: the test formulation was given in the first period, and reference formulation was given in the second period
Group B:Fed condition: the reference formulation was given in the first period, and test formulation was given in the second period
Group C:Fasting condition: the test formulation was given in the first period, and reference formulation was given in the second period
Group D:Fasting condition: the reference formulation was given in the first period, and test formulation was given in the second period
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria in order to be included in this trial: 1) Gender: Male or female healthy subjects; 2) Age: 18-50 years old (including 18 and 50 years old); 3) Weight: Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and the body mass index [BMI=weight (kg)/height 2 (m2)] should be within the range of 19.0 to 26.0kg/m2 (including 19.0 and 26.0); 4) The subjects fully understand the purpose, nature, method, and potential adverse reactions of the experiment, voluntarily act as subjects, and sign an informed consent form before any research procedure begins; 5) The subject has no fertility plan, no sperm or egg donation plan within 3 months after signing the informed consent form and voluntarily adopts effective contraceptive measures; 6) The subjects are able to communicate well with the researchers and complete the study in accordance with the research regulations. Those who do not meet any of the above conditions shall not be selected.
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria will be excluded: 1) Abnormalities judged by clinicians to be clinically significant, including vital signs, physical examination, 12 lead ECG, CT examination or clinical laboratory examination; 2) Individuals with a history of severe illnesses in the cardiovascular system, endocrine system, urogenital system, digestive system (such as habitual constipation, chronic diarrhea, chronic gastritis, or gastric and duodenal ulcers), blood and lymphatic system, respiratory system, nervous system, psychiatric system, etc., or currently suffering from these systemic diseases; 3) Allergy: Individuals who have previously been allergic to pirenzepine, any components in pirenzepine preparations, or similar drugs; Individuals who are allergic to lactose; Individuals who are allergic to other drugs or food factors; Individuals with a constitution prone to allergic symptoms such as rash and urticaria; 4) Those who have received any previous gastrointestinal surgery except appendectomy and herniotomy (such as gastrointestinal resection, cholecystectomy and other operations that affect absorption and metabolism) or who have undergone major surgery within 6 months before screening; 5) Within 30 days before the first administration, those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotic, verapamil, fluoroquinolones, antihistamines); 6) Those who have used any medication (including prescription drugs, over-the-counter drugs, vitamin supplements, or Chinese herbal medicines) or health products within 2 weeks before the first administration; 7) Those who have received the vaccine within 14 days before the first administration, or those who plan to receive the vaccine during the trial period; 8) Those who are positive for drug abuse screening, or have a history of drug abuse within the past five years, or have used drugs within the first three months of screening; 9) Individuals with special dietary requirements, unable to comply with the provided diet and corresponding regulations 10) Individuals with difficulty swallowing; 11) Individuals who are intolerant of skin puncture, dizziness, or poor blood collection vessel conditions; 12) Subjects engaged in occupations that require high-altitude work, vehicle driving, and other activities that require high levels of motor coordination ability; 13) Individuals who consume excessive amounts of tea, coffee, caffeinated beverages, or grapefruit rich beverages or foods daily (8 or more cups per day, 1 cup=250mL) for the first 3 months of screening; Or those who consume any xanthine like (caffeine, theophylline, theobromine, and madeline) foods or beverages, including coffee, tea, chocolate, or those who consume grapefruit, dragon fruit, mango, grapefruit, lime, carambola, or foods or beverages prepared from them within 48 hours before the first administration of the study, or those who exercise vigorously; 14) Those who smoke heavily (with an average daily smoking volume of 5 or more cigarettes) within the first 6 months of screening; Those who cannot stop using any tobacco products during the trial period; 15) Drinking more than 14 units of alcohol per week within 6 months before screening (1 standard unit is equal to 17.5mL or 14g pure alcohol, about equal t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of perampanel;Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event; | — |
Countries
China
Contacts
Public ContactHan Yangyun,Fan Lian-Lian
Deyang People's Hospital
Outcome results
None listed