epilepsy
Conditions
Interventions
Three groups:levetiracetam injection versus levetiracetam tablet
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be selected: (1) Male, aged 18 ~ 40 years old, the age difference of the same batch of subjects is not more than 10 years; (2) The weight of the subject should not be lower than 50kg, and the body mass index should be between 19 and 24; (3) Healthy physical examination (including physical examination, medical history, vital signs, electrocardiogram and clinical laboratory examination results) is qualified.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: (1) When the physical examination and laboratory examination are beyond the normal range and the investigator believes that it has clinical significance; (2) Known to be allergic to levetiracetam or have a history of allergy to other drugs; (3) History of acute and chronic gastrointestinal diseases and diseases of important organs such as heart, liver and kidney; diabetes, hyperthyroidism, Parkinson's syndrome, or any other diseases or physiological conditions known to interfere with the test results; (4) There is a history of blood system diseases or obvious bleeding tendency; (5) Have chronic mental illness or mental abnormality; (6) Have used any other drugs (including traditional Chinese medicine) within 2 weeks before the test; (7) A history of drug abuse; (8) The subject smoked excessively (> 5 cigarettes / day); or the smoker could not be interrupted during the trial; (9) The subject drank more than 28 units of alcohol per week (1 unit = 285ml beer or 25ml spirits or 1 glass of wine), or could not interrupt the drinker during the test; (10) Subjects drank too much caffeinated beverages (> 4 cups / day); or those who could not interrupt caffeinated beverages during the trial; (11) Participated in other drug trials within 3 months before participating in this trial; (12) There was severe blood loss or blood or plasma donation within 3 months before starting the test; (13) The investigator believes that any other factors that are not suitable for the subject to enter this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in blood; | — |
Countries
China
Contacts
Public ContactYimin Cui
Peking University First Hospital
Outcome results
None listed