Phase I clinical trial of cefditoren pivoxil (ME1207). Tolerance in healthy volunteers.
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.
Li
J T
JT
Institute of Clinical Phamacology, Beijing Medical University, China.
Hou
F
F
Lu
H
H
Li
T Y
TY
Li
H
H
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D019518:Postprandial Period
D002511:Cephalosporins; C057710:cefditoren pivoxil