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Bioequivalence Fasting Study in Patients

Information source: Amneal Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Asenapine Sublingual Tablets 10 mg (Drug); Asenapine Sublingual Tablets 10 mg (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Amneal Pharmaceuticals, LLC

Official(s) and/or principal investigator(s):
Ashutosh Jani, MD, Principal Investigator, Affiliation: Accutest Reserach laboratories (i) Pvt. Ltd.

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AUC 0-tau

Cmax

Secondary outcome:

Cmin

Tmax

Cavg

Percentage Fluctuation

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Shri Hatkesh Healthcare Foundation, Junagadh, Gujurat 362 001, India

Divyam Hospital, Surat, Gujurat 395 001, India

Additional Information

Starting date: November 2013
Last updated: June 25, 2014

Page last updated: August 23, 2015

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