Bioequivalence Fasting Study in Patients

Amneal Pharmaceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Schizophrenia

Treatments

Drug: Asenapine Sublingual Tablets 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02072954

ARL/CT/13/003

CTRI No. CTRI/2013/11/004152 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients of either sex with age between 18 to 65 years (both inclusive) and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months.
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.
Females of childbearing (who has not completed 01 year after menopause & have not gone through hysterectomy or bilateral tubal ligation) potential must have a negative pregnancy test (at screening, before randomization and before check-in to housing) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study.

Exclusion criteria

History of allergic or adverse reactions to asenapine maleate or olanzapine as judged by investigator
If consuming tobacco orally (spit tobacco, gutka, pan masala, pan, etc.)
A history of severe hepatic impairment, drug induced leukopenia/ neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease
Abnormal laboratory results
A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of asenapine maleate
History of multiple syncopal episodes
History of epilepsy or risk for seizures
Any condition/ Abnormal baseline findings that in the investigators' judgment might increase the risk to the patient (e.g. Significant orthostatic hypotension defined as a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing) or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
A history of alcohol or drug dependence by DSM-IV criteria during the 6-month period immediately prior to study entry
Positive tests for drug or alcohol abuse at screening or baseline
Use of any of the following medication in the 14 days preceding enrollment: Strong CYP3A4 inhibitors, Strong CYP3A4 inducers, CYP1A2 inhibitors, Antihypertensive medication or any medication that might predispose to orthostatic hypotension, Drugs known to suppress bone marrow function, medications known to prolong the QTc interval.
Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening.
Blood donation/ loss exceeding 550 mL within last 90 days.
Any expected changes in concomitant medications during the period of study
Compliance with outpatient medication schedule not expected