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Bioequivalence Fasting Study in Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02072954
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Collaborator:
Accutest Research Laboratories (I) Pvt. Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Asenapine Sublingual Tablets 10 mg Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Asenapine Sublingual Tablets
Asenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days
Drug: 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

Active Comparator: Saphris Subligual Tablets
Asenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each.
Drug: Asenapine Sublingual Tablets 10 mg
Round, white to off-white sublingual tablets, with "10" on one side within a circle




Primary Outcome Measures :
  1. AUC 0-tau [ Time Frame: Dosing interval on day 7 ]
    The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.

  2. Cmax [ Time Frame: Dosing interval on day 7 ]
    Maximum measured plasma concentration over the steady state doing interval


Secondary Outcome Measures :
  1. Cmin [ Time Frame: Dosing interval on day 7 ]
    Minimum measured plasma concentration over the steady state dosing interval

  2. Tmax [ Time Frame: Dosing interval on day 7 ]
    Time the maximum measured plasma concentration over the steady state dosing interval

  3. Cavg [ Time Frame: Dosing interval on day 7 ]
    Average calculated plasma concentration over the steady state dosing interval

  4. Percentage Fluctuation [ Time Frame: Dosing interval on day 7 ]
    [Cmax - Cmin/ Cavg] x 100



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072954


Locations
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India
Shri Hatkesh Healthcare Foundation
Junagadh, Gujurat, India, 362 001
Divyam Hospital
Surat, Gujurat, India, 395 001
Sponsors and Collaborators
Amneal Pharmaceuticals, LLC
Accutest Research Laboratories (I) Pvt. Ltd.
Investigators
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Principal Investigator: Ashutosh Jani, MD Accutest Reserach laboratories (i) Pvt. Ltd.
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Responsible Party: Amneal Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02072954    
Other Study ID Numbers: ARL/CT/13/003
CTRI No. CTRI/2013/11/004152 ( Other Identifier: Clinical Trials Registration India )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs