Bio-equivalence Study Between SAPHRIS and Asenapine

Completed · Phase 1

Conditions studied: Schizophrenia, Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT01948024

Run by

Sun Pharmaceutical Industries Limited

People needed

65

Starts

2013-07-01

Expected to finish

2013-08-01

Last updated by the study team

2021-04-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Woodland International Research Group, Inc. — Little Rock, Arkansas, United States
• Clinical Innovations, Inc — Costa Mesa, California, United States
• Collaborative Neuroscience Network, LLC — Garden Grove, California, United States
• Compass Research North, LLC — Leesburg, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• New Hope Clinical Research — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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