The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers
The proposed study is a single centre, bioavailability, open-label, randomized, single-dose, 3-period, 6-sequence, crossover study under fasting conditions. Each volunteer will be given a single dose of the Test formulation in two study periods (with and without water), and a single dose of the Reference formulation (with water) in the other study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days
The rate extent of absorption of aripiprazole OSF 10mg versus Abilify ® 10mg tablet
Time frame: Baseline to 28 days
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