Bioequivalence Fasting Study in Patients

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Asenapine Sublingual Tablets 10 mg

• Registration Number: NCT02072954
• Lead Sponsor: Amneal Pharmaceuticals, LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-02
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Status Verified: 2014-06
• Study Completion: 2014-06
• Disposition First Submitted: 2014-06-25
• Disposition First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Disposition First Posted: 2014-06-27
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Asenapine Sublingual Tablets	Asenapine Sublingual Tablets 10 mg	Asenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days
Saphris Subligual Tablets	Asenapine Sublingual Tablets 10 mg	Asenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each.

Primary Outcome Measures

Name	Time	Method
AUC 0-tau	Dosing interval on day 7	The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.
Cmax	Dosing interval on day 7	Maximum measured plasma concentration over the steady state doing interval

Secondary Outcome Measures

Name	Time	Method
Cmin	Dosing interval on day 7	Minimum measured plasma concentration over the steady state dosing interval
Tmax	Dosing interval on day 7	Time the maximum measured plasma concentration over the steady state dosing interval
Cavg	Dosing interval on day 7	Average calculated plasma concentration over the steady state dosing interval
Percentage Fluctuation	Dosing interval on day 7	\[Cmax - Cmin/ Cavg\] x 100

Trial Locations

Locations (2)

Divyam Hospital; 🇮🇳 Surat, Gujurat, India

Shri Hatkesh Healthcare Foundation; 🇮🇳 Junagadh, Gujurat, India