Li J T, Hou F, Lu H, Li T Y, Li H
Institute of Clinical Phamacology, Beijing Medical University, China.
Drugs Exp Clin Res. 1997;23(3-4):131-8.
A tolerance study to ME1207 was conducted in healthy volunteers using five single doses administered before a meal (50, 100, 200, 300 and 500 mg), a single 200 mg dose administered after a meal, and 200 mg administered every 12 h for 7 days. No subjective symptoms or changes in haematological and biochemical examinations and urinalysis were observed after single administration of 50 to 500 mg Four subjects complained of minimal upper abdominal discomfort when 200 mg was administered every 12 h for 7 days, but this symptom disappeared without remedial action in all cases. Therefore ME1207 was thought to be safe when orally administered at the above-mentioned doses by the above-mentioned administration methods.
在健康志愿者中开展了一项针对ME1207的耐受性研究，采用了五种单剂量，在饭前给药（50、100、200、300和500毫克），一种单剂量200毫克在饭后给药，以及每12小时给药200毫克，持续7天。单次给予50至500毫克后，未观察到主观症状或血液学、生化检查及尿液分析的变化。在每12小时给予200毫克，持续7天的情况下，有4名受试者抱怨有轻微上腹部不适，但在所有病例中，该症状未经治疗即消失。因此，ME1207按上述给药方法、以上述剂量口服给药时被认为是安全的。
