Bioequivalence study of asenapine sublingual tablets in patients
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2013/11/004152
- Lead Sponsor
- Amneal Pharmaceuticals LLC USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
1.Adult patients of either sex with age between 18 to 65 years (both inclusive) and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months.
2.Willing and able to comply with study visit schedule and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.
3.Females of childbearing (who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation) potential must have a negative pregnancy test (at screening, before randomization and before check-in to housing) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study.
The Patients with any of the following criteria should be excluded:
1. History of allergic or adverse reactions to asenapine maleate or olanzapine as judged by investigator
2. If consuming tobacco orally (spit tobacco, gutka, pan masala, pan, etc.)
3. A history of severe hepatic impairment, drug induced leukopenia/ neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
4. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease
5. Abnormal laboratory results as below:
• Reactive to antiHIV, HBSAg & anti HCV
• Anemia
• WBC count 4000/μL or mm3
• ANC count 2000/μL or mm3
• SGPT/ SGOT 2.5 times UNL
• Serum creatinine 1.5 times UNL
• Hyperprolactinemia
• QTc interval 500 ms (at screening or randomization)
6. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
7. A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of asenapine maleate
8. History of multiple syncopal episodes
9. History of epilepsy or risk for seizures
10. Any condition/ Abnormal baseline findings that in the investigatorsâ?? judgment might increase the risk to the patient (e.g. Significant orthostatic hypotension defined as 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) or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
11. A history of alcohol or drug dependence by DSM-IV criteria during the 6-month period immediately prior to study entry
12. Positive tests for drug or alcohol abuse at screening or baseline
13. Use of any of the following medication in the 14 days preceding enrolment:
• Strong CYP3A4 inhibitors
• Strong CYP3A4 inducers
• CYP1A2 inhibitors
• Antihypertensive medication or any medication that might predispose to orthostatic hypotension
• Drugs known to suppress bone marrow function
• Medications known to prolong the QTc interval.
14. Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening.
15. Blood donation/ loss exceeding 550 mL within last 90 days.
16. Any expected changes in concomitant medications during the period of study
17. Compliance with outpatient medication schedule not expected
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC0-tau & CmaxTimepoint: Dosing interval on day 7
- Secondary Outcome Measures
Name Time Method CavgTimepoint: Dosing interval on day 7;CminTimepoint: Dosing interval on day 7;fluctuation rateTimepoint: Dosing interval on day 7;TmaxTimepoint: Dosing interval on day 7