Beijing Bo Li Wei Kang Medical Research Institute

Using placebo as control, the average monthly frequency of partial epilepsy during the 16-week treatment period (maintenance dose period) was evaluated to explore the effective dose and optimal course of treatment of clobutamide tablets for partial epilepsy in adults, providing a basis for medication for Phase III clinical trials. The safety of clobutamide tablets in clinical use was preliminarily explored through laboratory tests, adverse events (frequency, severity, nature, duration), physical and neurological examinations, etc.

A phase I single oral pharmacokinetic study of chloramphenicol tablets was conducted on healthy adult subjects to determine its pharmacokinetic characteristics of single administration and provide a basis for multiple administration tolerance/human pharmacokinetics and phase II clinical studies.

Based on the results of single oral human tolerance and pharmacokinetics, multiple oral dosing tolerance/human pharmacokinetics studies were conducted to determine its pharmacokinetic characteristics of multiple dosing and provide a basis for Phase II clinical trials.