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CompletedNCT02072954

Comparison of Two Asenapine Tablet Products in People With Schizophrenia

About this titleRead the official source — NCT02072954
Medication studyAges 18–65India
The study in practice

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Who was this study for?

Listed age limits: 18 years to 65 years.

Listed locations
Jūnāgadh and 1 more locationSee all locations and recruitment
Study phase
Phase 2 / Phase 3This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.

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Study clarity

Study information

Study start dateNovember 2013
Recruitment status
Completed
Enrollment listed in the registry
48
Sponsor
Amneal Pharmaceuticals, LLC
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2 / Phase 3This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
Locations
India
Age range
From 18 Years to 65 Years
Official registry ID
NCT02072954
Official title
Show the full 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.

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Recruitment & locations

Completed

Jūnāgadh · Surat

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FAQ

Questions about this study

Who is behind this study?

The study sponsor is Amneal Pharmaceuticals, LLC.

Did this study involve medication?

Yes. The study involved medication, including Asenapine Sublingual Tablets 10 mg.

Who was this study for?

Listed age limits: 18 years to 65 years.

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