Bio-equivalence Study Between SAPHRIS and Asenapine

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: bioRASI, LLC; Sun Pharmaceutical Industries Limited
• Collaborators: bioRASI, LLC; Sun Pharmaceutical Industries Limited
• Treatments: Asenapine

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