TABLE 1.

Dosing regimens

Cohorta (n)PeriodbDose on day:
1 (i.v. loading)2-7 (i.v. maintenance)8-14 (oral maintenance)
1 (28)16 mg/kg b.i.d.3 mg/kg b.i.d.200 mg b.i.d. (days 8-13), 200 mg o.d.c (day 14)
26 mg/kg b.i.d.5 mg/kg b.i.d.400 mg b.i.d. (days 8-13), 400 mg o.d. (day 14)
2 (14)6 mg/kg b.i.d.4 mg/kg b.i.d.300 mg b.i.d. (days 8-13), 300 mg o.d. (day 14)
  • a Subjects received either active drug or matched placebo in the regimens shown (active/placebo ratio, 1:1) throughout the study.

  • b For cohort 1, there was a washout period of at least 7 days between periods 1 and 2.

  • c o.d., once a day.