Table 1.
Summary of clinical trials of sitafloxacin used in the present analysis
Study no. | Subject description | Dosage | Number of subjects/patients | Number of serum samples | Reference |
---|---|---|---|---|---|
DU6859-01 | Healthy male subjects (phase I) | 25, 50, 100, or 200 mg, single dose | 24 | 310 | [3, 4] |
DU6859-01, 02 DU6859a-03 | Healthy male subjects (phase I) | 50 or 100 mg, twice daily, and 100 mg, three times daily, 7 days | 18 | 535 | [4, 16] |
DU6859a-19 | Elderly patients with chronic respiratory tract disease (clinical pharmacology) | 50 or 100 mg, single dose | 10 | 50 | [16] |
DU6859a-28 | Healthy male elderly or nonelderly subjects (clinical pharmacology) | 100 mg, single dose | 11 | 101 | [6] |
DU6859a-37 | Renal-impaired subjects (clinical pharmacology) | 50 mg, single dose | 12 | 148 | [5] |
DU6859a-44 | Patients with respiratory tract infection (phase III, PK–PD study) | 50 or 100 mg, twice daily, 7 days | 137 | 354 | [15] |