Schizophrenia Clinical Trial
Official title:
A Multicentric, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Crossover, Multiple Dose, Steady State Bioequivalence Study of Asenapine Sublingual Tablets, 10 mg Manufactured by AMNEAL PHARMACEUTICALS, USA With Reference Product SAPHRIS® (Asenapine) Sublingual Tablets, 10 mg Manufactured by Catalent UK Swindon Zydis Ltd., Blagrove, Swindon, Wiltshire, SN5 8RU, UK; Distributed by Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, 08889, USA in Adult Human Male & Female Patients Under Fasting Condition.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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