Jt. Li et al., PHASE-I CLINICAL-TRIAL OF CEFDITOREN PIVOXIL (ME1207) - TOLERANCE IN HEALTHY-VOLUNTEERS, Drugs under experimental and clinical research, 23(3-4), 1997, pp. 131-138
A tolerance study to ME1207 was conducted in healthy volunteers using
live single doses administered before a meal (50, 100, 200, 300 and 50
0mg), a single 200mg dose administered after a meal, and 200 mg admini
stered every 12 h for 7 days. No subjective symptoms or changes in hae
matological and biochemical examinations and urinalysis were observed
after single administration of 50 to 500mg. Four subjects complained o
i minimal upper abdominal discomfort when 200mg was administered every
12h for 7 days, but this symptom disappeared without remedial action
in ail cases, Therefore, ME1207 was thought to be sale when orally adm
inistered at the above-mentioned doses by the above-mentioned administ
ration methods.