Bioequivalence Fasting Study in Patients

NCT ID: NCT02072954

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Asenapine Sublingual Tablets

Asenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days

Group Type: EXPERIMENTAL

Asenapine Sublingual Tablets 10 mg

Intervention Type: DRUG

White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side

Saphris Subligual Tablets

Asenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each.

Group Type: ACTIVE_COMPARATOR

Asenapine Sublingual Tablets 10 mg

Intervention Type: DRUG

Round, white to off-white sublingual tablets, with "10" on one side within a circle

Interventions

Asenapine Sublingual Tablets 10 mg

White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side

Intervention Type: DRUG

Asenapine Sublingual Tablets 10 mg

Round, white to off-white sublingual tablets, with "10" on one side within a circle

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accutest Research Laboratories (I) Pvt. Ltd.

INDUSTRY

Sponsor Role: collaborator

Amneal Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashutosh Jani, MD

Role: PRINCIPAL_INVESTIGATOR

Accutest Reserach laboratories (i) Pvt. Ltd.

Locations

Shri Hatkesh Healthcare Foundation

Jūnāgadh, Gujurat, India

Divyam Hospital

Surat, Gujurat, India

Countries

India

Other Identifiers

CTRI No. CTRI/2013/11/004152

Identifier Type: OTHER

Identifier Source: secondary_id

ARL/CT/13/003

Identifier Type: -

Identifier Source: org_study_id