To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
RU801
Moscow, Russia
The area under the plasma concentration-time curve
Time frame: from 0 to 72 hours post-dose
The maximum observed concentration (Cmax)
Time frame: from 0 to 72 hours post-dose
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single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2