A Multicentric, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Crossover, Multiple Dose, Steady State Bioequivalence Study of Asenapine Sublingual Tablets, 10 mg Manufactured by AMNEAL PHARMACEUTICALS, USA With Reference Product SAPHRIS® (Asenapine) Sublingual Tablets, 10 mg Manufactured by Catalent UK Swindon Zydis Ltd., Blagrove, Swindon, Wiltshire, SN5 8RU, UK; Distributed by Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, 08889, USA in Adult Human Male & Female Patients Under Fasting Condition.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- AUC 0-tau
研究概览
简要总结
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg.
详细描述
To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg following a multiple-dose administration in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base.
To monitor the safety and tolerability of a multiple doses of asenapine sublingual tablets 10 mg in adult human patients who are receiving a stable twice daily dose of asenapine maleate EQ 10 mg base.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •Females of childbearing (who has not completed 01 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.
排除标准
- •History of allergic or adverse reactions to asenapine maleate or olanzapine as judged by investigator
- •If consuming tobacco orally (spit tobacco, gutka, pan masala, pan, etc.)
- •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
- •Abnormal laboratory results
- •A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
- •A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of asenapine maleate
- •History of multiple syncopal episodes
- •History of epilepsy or risk for seizures
- •Any condition/ Abnormal baseline findings that in the investigators' 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.
- •A history of alcohol or drug dependence by DSM-IV criteria during the 6-month period immediately prior to study entry
- •Positive tests for drug or alcohol abuse at screening or baseline
- •Use of any of the following medication in the 14 days preceding enrollment: 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.
- •Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening.
- •Blood donation/ loss exceeding 550 mL within last 90 days.
- •Any expected changes in concomitant medications during the period of study
- •Compliance with outpatient medication schedule not expected
研究组 & 干预措施
Asenapine Sublingual Tablets
Asenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days
干预措施: Asenapine Sublingual Tablets 10 mg (Drug)
Saphris Subligual Tablets
Asenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each.
干预措施: Asenapine Sublingual Tablets 10 mg (Drug)
结局指标
主要结局
AUC 0-tau
时间窗: Dosing interval on day 7
The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.
Cmax
时间窗: Dosing interval on day 7
Maximum measured plasma concentration over the steady state doing interval
次要结局
- Cmin(Dosing interval on day 7)
- Tmax(Dosing interval on day 7)
- Cavg(Dosing interval on day 7)
- Percentage Fluctuation(Dosing interval on day 7)