A multicenter, open label, randomized, balanced, two treatment, three period, three sequence, reference-scaled, multiple dose, comparative oral bioavailability study of Asenapine Maleate EQ 10 mg base sublingual tablet Manufactured by Watson Pharma Pvt. Ltd., India with SAPHRIS® ( Asenapine Maleate tablets) sublingual tablets EQ 10 mg base of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA in adult human patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder under Fasting steady-state condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- To compare and evaluate the multiple-dose oral bioavailability of Asenapine Maleate EQ 10 mg base sublingual tablet Manufactured by Watson Pharma Pvt. Ltd., India with SAPHRIS® ( Asenapine Malate tablets) sublingual tablets EQ 10 mg base of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA in adult human patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder as monotherapy under Fasting steady-state condition
研究概览
简要总结
This is a multicenter, open label, randomized, balanced, two treatment, three period, three sequence, reference-scaled, multiple dose, comparative oral bioavailability study of Asenapine Maleate EQ 10 mg base sublingual tablet Manufactured by Watson Pharma Pvt. Ltd., India with SAPHRIS®( Asenapine Maleate tablets) sublingual tablets EQ 10 mg base of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA in adult human patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder under Fasting steady-state condition. The study duration for each subject will be of 22 days. Patients should be appropriate candidates for asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months will be eligible for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Men and women, 18 years of age or older.
- •2.Ability to provide informed consent prior to participation in the study.
- •3.Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.
- •4.Adequate organ function, defined as the following: total bilirubin < 1.5 x upper limit of normal (ULN) SGOT and SGPT < 2.5 x ULN,Creatinine < 1.5 x ULN Platelets > 100 x 10 raise to 9 /L 5.No history of addiction to any recreational drug or drug dependence 6.No participation in any clinical study within the past 60 days.
- •7.Clinically acceptable ECG in opinion of an Investigator.
排除标准
- •1.A history of allergic or adverse reactions to asenapine maleate or any comparable or similar product 2.A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease 3.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson’s disease 4.A total white blood cell count below 4000/cmm, or an absolute neutrophil count below 2000/cmm 5.A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic) 6.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) 7.Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension 8.A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of asenapine maleate 9.A history of epilepsy or risk for seizures 10.Concurrent use of other drugs known to suppress bone marrow function 11.Expected changes in concomitant medications during the period of study 12.Positive tests for drug or alcohol abuse at baseline 13.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 14.Compliance with outpatient medication schedule not expected 15.History of multiple syncopal episodes 16.Patients who are: •Pregnant •Breast feeding •Of childbearing potential without a negative pregnancy test prior to baseline •Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial •Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery •Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
- •â€¢Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent 17.Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
- •18.Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure, neuropsychiatric infection or disease.
- •19.History of difficulty with donating blood or difficulty in accessibility of veins.
- •20.An unusual or abnormal diet, for whatever reason e.g. religious fasting.
结局指标
主要结局
To compare and evaluate the multiple-dose oral bioavailability of Asenapine Maleate EQ 10 mg base sublingual tablet Manufactured by Watson Pharma Pvt. Ltd., India with SAPHRIS® ( Asenapine Malate tablets) sublingual tablets EQ 10 mg base of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA in adult human patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder as monotherapy under Fasting steady-state condition
时间窗: The pre-dose blood sample on Day 5, 6, 7 12, 13, 14, 19, 20 and 21 will be collected 3.0 ml within 5 minutes before dosing time. On day 7, 14 and 21, the post-dose blood samples of 3.0 mL each will be drawn at 0.5, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00 hrs following drug administration in each period.
次要结局
- To monitor the adverse events and to ensure the safety of Patient(NA)