To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg.
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg following a multiple-dose administration in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base. To monitor the safety and tolerability of a multiple doses of asenapine sublingual tablets 10 mg in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side
Round, white to off-white sublingual tablets, with "10" on one side within a circle
Shri Hatkesh Healthcare Foundation
Jūnāgadh, Gujurat, India
Divyam Hospital
Surat, Gujurat, India
AUC 0-tau
The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.
Time frame: Dosing interval on day 7
Cmax
Maximum measured plasma concentration over the steady state doing interval
Time frame: Dosing interval on day 7
Cmin
Minimum measured plasma concentration over the steady state dosing interval
Time frame: Dosing interval on day 7
Tmax
Time the maximum measured plasma concentration over the steady state dosing interval
Time frame: Dosing interval on day 7
Cavg
Average calculated plasma concentration over the steady state dosing interval
Time frame: Dosing interval on day 7
Percentage Fluctuation
\[Cmax - Cmin/ Cavg\] x 100
Time frame: Dosing interval on day 7
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