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Bio-equivalence Study Between SAPHRIS and Asenapine (ASN)

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: NCT01948024
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : February 24, 2014
Sponsor:
Collaborator:
Sun Pharmaceutical Industries Limited
Information provided by (Responsible Party):
bioRASI, LLC

Brief Summary:

This is a Multiple-dose, steady state, three-way reference-replicated crossover study.

The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.


Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Drug: SAPHRIS Drug: Asenapine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open-label, Randomized, Two Treatment, Multi-site, Multiple Dose, Steady State, Three-way, Reference-replicated Crossover, Pharmacokinetic Study to Determine the In-vivo Bioequivalence Between Asenapine 10 mg Sublingual Tablet and SAPHRIS® (Asenapine) 10 mg Sublingual Tablet
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Reference Arm - SAPHRIS
10 mg BID sublingual tablet
Drug: SAPHRIS
10 mg BID sublingual tablet

Experimental: Test Arm - Asenapine
10 mg BID sublingual tablet
Drug: Asenapine
10 mg BID sublingual tablet




Primary Outcome Measures :
  1. Change in Concentration of study medication in the blood at multiple time-points [ Time Frame: 17 Time Points (1 on Day 5, 1 on Day 6, 15 on Day 7) ]
    The primary outcome of this Study is to show bio-equivalence between Asenapine and SAPHRIS. This will be accomplished by measuring the change in concentration of the study medication in the blood at multiple time-points.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and/or non-pregnant female subjects aged 18 to 80 years of age
  2. For females of child-bearing potential, the subject must be willing to practice a clinically accepted method of birth control
  3. Receiving a stable twice daily dose of Asenapine Maleate EQ 10 mg base sublingual tablets for at least 3 months prior to randomization
  4. Subjects will be otherwise healthy as determined by the investigator in reference to physical examination, medical history and routine hematologic and biochemical tests
  5. Able to obtain written informed consent for the study by the subject or Subject's Legally Acceptable Representative (LAR). If the subject or his/her LAR is unable to read/write, and impartial witness will be present during the entire consenting process who must append his/her signatures to the consent form

Exclusion Criteria:

  1. A history of any clinically significant allergic or adverse reactions to asenapine maleate or any comparable or similar product
  2. QTc > 450 msec in male subject or QTc > 470 msec in female subjects at screening
  3. Heart rate at screening less than 50 bts/min
  4. Hypokalemia (defined as serum or plasma potassium less than 3.5 mM or mEq/L) and/or Hypomagnesaemia (defined as serum magnesium less than 0.7 mEq/L) at screening.
  5. A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
  6. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease
  7. A total white blood cell count below 4000/mL, or an absolute neutrophil count below 2000/mL
  8. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
  9. Significant orthostatic hypotension (i.e., 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)
  10. Concurrent use of antihypertensive medication or any medication that can predispose to orthostatic hypotension, unless receiving stable dose of those medications for at least 3 months prior to randomization.
  11. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Asenapine
  12. A history of epilepsy or risk for seizures
  13. Concurrent use of other drugs known to suppress bone marrow function
  14. Expected changes in concomitant medications during the period of study
  15. Positive tests for drug or alcohol abuse at screening or baseline
  16. A history of alcohol or drug dependence by Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study entry
  17. Has participated in another clinical research study within 30 days prior to randomization
  18. Compliance with outpatient medication schedule not expected
  19. History of multiple syncopal episodes
  20. Any other clinically significant condition that the investigator thinks puts the subject at risk

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): NCT01948024


Locations
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United States, Arkansas
Woodland International Research Group, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Clinical Innovations, Inc
Costa Mesa, California, United States, 92280
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
United States, Florida
Compass Research North, LLC
Leesburg, Florida, United States, 34748
Advanced Pharma CR, LLC
Miami, Florida, United States, 33136
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, North Carolina
New Hope Clinical Research
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
bioRASI, LLC
Sun Pharmaceutical Industries Limited
Investigators
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Principal Investigator: David Walling, MD Collaborative Neuroscience Network, LLC
Principal Investigator: Robert A Riesenberg, MD Atlanta Center for Medical Research
Principal Investigator: Kurian Abraham, MD New Hope Clinical Research, Inc.
Principal Investigator: Evagelos Coskinas, MD Clinical Innovations
Principal Investigator: James S. McDonough, MD Compass Research North, LLC
Principal Investigator: Gilbert R. Weiner, DO Advanced Pharma CR, LLC
Principal Investigator: Jim G. Aukstuolis, MD Woodland International Research Group, Inc.
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Responsible Party: bioRASI, LLC
ClinicalTrials.gov Identifier: NCT01948024    
Other Study ID Numbers: ASN-101
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs