NCT01948024CompletedPhase 1
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
Sun Pharmaceutical Industries Limited7 sites in 1 country65 target enrollmentStarted: July 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 65
- Locations
- 7
- Primary Endpoint
- Change in Concentration of study medication in the blood at multiple time-points
Study Overview
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.
Detailed Description
Molecule Name Asenapine Country of submission US
PRODUCT DETAILS
Test formulation
Drug name: Asenapine Sublingual Tablet EQ 10mg base Manufactured by: Sun Pharmaceutical Industries, Ltd.
Reference formulation
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
- •Has participated in another clinical research study within 30 days prior to randomization
- •Compliance with outpatient medication schedule not expected
- •History of multiple syncopal episodes
- •Any other clinically significant condition that the investigator thinks puts the subject at risk
Arms & Interventions
Reference Arm - SAPHRIS
Active Comparator
10 mg BID sublingual tablet
Intervention: SAPHRIS (Drug)
Test Arm - Asenapine
Experimental
10 mg BID sublingual tablet
Intervention: Asenapine (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
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