To compare bio availability of Asenapine Sublingual Tablets in adult human male and female schizophrenic and bipolar I disorder patients

A multicentric open label randomized balanced two treatment two period two sequence crossover multiple dose steady state bioequivalence study of Asenapine Sublingual Tablets 10 mg manufactured by AMNEAL PHARMACEUTICALS with 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 schizophrenic &bipolar I disorder patients under fasting conditions

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014374

Enrollment

Registered

2018-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- schizophrenic &bipolar I disorder patients

Interventions

Intervention1: Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS: To ensure optimal absorption, patients will be instructed to place the tablet under the tongue and allow it t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients of schizophrenic & bipolar I disorder either sex aged between 18 to 65 years (both inclusive) and on a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily for at least three months. 2. Patients having BMI from 18 to 27 kg/m2(both inclusive) 3. Willing and able to comply with study visit schedule and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative. 4. Females of childbearing potential

Exclusion criteria

Exclusion criteria: 1. History of allergic or adverse reactions to asenapine maleate or olanzapine as judged by investigator 2. If consuming tobacco orally (spit tobacco, gutka, pan masala, pan, etc.) 3. A history of severe hepatic impairment, drug induced leukopenia/ neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease 4. Concurrent primary psychiatric or neurological diagnosis,including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease 5. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic) 6. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of asenapine maleate 7. History of multiple syncopal episodes 8. History of epilepsy or risk for seizures

Design outcomes

Primary

Measure	Time frame
To characterize the pharmacokinetic profile of Asenapine sublingual tablets 10 mg of Amneal Pharmaceuticals with SAPHRIS in Patients of Schizophrenia or Bipolar I disorder patientsTimepoint: 1,2,4,6,8,10 and 12 hours	—

Secondary

Measure	Time frame
To monitor the adverse events and to ensure the safety of PatientTimepoint: From screening till end of study	—

Countries

India

Contacts

Public ContactDr Prayag Shah

Amneal Pharmaceuticals Pvt. Ltd.

dr.prayag@amneal.com91-79-67778300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026