Bioequivalence Fasting Study in Patients

NCT02072954 | Completed Phase 2 DMC

• 2 other identifiers: ARL/CT/13/003CTRI No. CTRI/2013/11/004152
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• AUC 0-tau

  The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.

  Dosing interval on day 7

• Cmax

  Maximum measured plasma concentration over the steady state doing interval

  Dosing interval on day 7

Secondary Outcomes (4)

• Cmin

  Dosing interval on day 7

• Tmax

  Dosing interval on day 7

• Cavg

  Dosing interval on day 7

• Percentage Fluctuation

  Dosing interval on day 7

Study Arms (2)

Asenapine Sublingual Tablets

EXPERIMENTAL

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

Drug: Asenapine Sublingual Tablets 10 mg

Saphris Subligual Tablets

ACTIVE COMPARATOR

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

Drug: Asenapine Sublingual Tablets 10 mg

Interventions

Asenapine Sublingual Tablets 10 mg 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

Asenapine Sublingual Tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead
• Accutest Research Laboratories (I) Pvt. Ltd.: collaborator

Study Sites (2)

Shri Hatkesh Healthcare Foundation

Jūnāgadh, Gujurat, 362 001, India

Location

Divyam Hospital

Surat, Gujurat, 395 001, India

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Ashutosh Jani, MD

  Accutest Reserach laboratories (i) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 27, 2014

Record last verified: 2014-06

Locations

IN (2)