Bio-equivalence Study Between SAPHRIS and Asenapine

NCT01948024 | Completed Phase 1

• 1 other identifier: ASN-101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 7

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.

Conditions

Schizophrenia; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Concentration of study medication in the blood at multiple time-points

  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.

  17 Time Points (1 on Day 5, 1 on Day 6, 15 on Day 7)

Study Arms (2)

Reference Arm - SAPHRIS

ACTIVE COMPARATOR

10 mg BID sublingual tablet

Drug: SAPHRIS

Test Arm - Asenapine

EXPERIMENTAL

10 mg BID sublingual tablet

Drug: Asenapine

Interventions

SAPHRIS DRUG

10 mg BID sublingual tablet

Reference Arm - SAPHRIS

Asenapine DRUG

10 mg BID sublingual tablet

Test Arm - Asenapine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or non-pregnant female subjects aged 18 to 80 years of age
• For females of child-bearing potential, the subject must be willing to practice a clinically accepted method of birth control
• Receiving a stable twice daily dose of Asenapine Maleate EQ 10 mg base sublingual tablets for at least 3 months prior to randomization
• Subjects will be otherwise healthy as determined by the investigator in reference to physical examination, medical history and routine hematologic and biochemical tests
• 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

You may not qualify if:

• A history of any clinically significant allergic or adverse reactions to asenapine maleate or any comparable or similar product
• QTc \> 450 msec in male subject or QTc \> 470 msec in female subjects at screening
• Heart rate at screening less than 50 bts/min
• 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.
• 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
• A total white blood cell count below 4000/mL, or an absolute neutrophil count below 2000/mL
• A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
• 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)
• 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.
• A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of Asenapine
• A history of epilepsy or risk for seizures
• Concurrent use of other drugs known to suppress bone marrow function
• Expected changes in concomitant medications during the period of study
• Positive tests for drug or alcohol abuse at screening or baseline

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead
• bioRASI, LLC: collaborator

Study Sites (7)

Woodland International Research Group, Inc.

Little Rock, Arkansas, 72211, United States

Location

Clinical Innovations, Inc

Costa Mesa, California, 92280, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Compass Research North, LLC

Leesburg, Florida, 34748, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33136, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Interventions

asenapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: September 23, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

US (7)