Α Randomized, Two-way, Two-treatment, Two-period, Crossover, Open Label, Laboratory-blind, Comparative Bioavailability Study at Steady State Between Paliperidone 100 mg Prolonged Release Suspension for Injection (Test Product) and Xeplion® 100 mg Prolonged Release Suspension for Injection (Reference Product) Following Multiple Intramuscular Injections (Five Doses in Each Period, One Dose Every 28 Days) Administration to Patients With Schizophrenia Who Are Already Receiving a Stable Regimen of Paliperidone Prolonged Release Suspension Via The Intramuscular Route
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Cmax(ss)
研究概览
简要总结
This clinical study will compare the equivalence of two products containing Paliperidone 100 mg in the form of a prolonged release suspension for injection in patients affected by schizophrenia who are already receiving this treatment. Each patient will receive both products (Test and Reference). In total, each patient will receive 10 doses (five doses of the Test product and five doses of the Reference product; one dose every 28 days). Furthermore, the two products (Test and Reference) will be compared with regard to their safety and tolerability.
详细描述
This study will be a randomized, two-way, two-treatment, two-period, crossover, open label, laboratory-blind, multiple dose study at steady state, under fasting conditions.
To main purpose of this study is to determine the relative bioavailability of Paliperidone 100 mg prolonged release suspension for injection (Pharmathen S.A, Greece) and Xeplion® (Paliperidone) 100 mg Prolonged Release Suspension for Injection (Janssen Pharmaceutica N.V., Belgium) following multiple Intramuscular Injections (five doses in each period, one dose every 28 days) administration to patients with schizophrenia who are already receiving a stable regimen of paliperidone prolonged release suspension via the intramuscular route.
The secondary objective of this study is to evaluate the safety and tolerability between the two products.
Five injections of Paliperidone 100 mg prolonged release suspension will be administered intramuscularly (in the deltoid muscle) to study patients in each period (one injection every 28 days).
A total of 70 patients will be randomized into two sequences (Test-Reference or Reference-Test).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 其他
- 盲法
- 开放（无盲法）
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
- The patient is suffering from Schizophrenia.
- The patient age is > 18 years and < 65 years old (inclusive).
- The patient has a body weight not less than 50 Kg and according to the BMI range (18.5 - 35 Kg/m2), (inclusive)
- The patient has received at least 3 doses of Paliperidone 100 mg Prolonged Release Suspension for Injection within the last 3 months.
- The patient is under fasting conditions (food and drinks) for at least 8 hours on the day of screening.
- The patient is available to volunteer for the entire study duration and is willing to adhere to all protocol requirements.
- The findings of the patient are within the range of clinical acceptability in medical history, physical examination, vital signs, ECG, and laboratory results.
- The legally acceptable representative signed the informed consent form and the patient is able to communicate with the investigator and comprehend study-related procedures.
- The patient agrees to use a condom if he is engaged in sexual activity with a woman of childbearing potential.
- A condom is required along with another medically acceptable contraceptive method. Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide).
- Female patients may be included but must comply with the following in order to be included:
- Women having the potential to become pregnant can be enrolled only if willing to use a clinically acceptable (i.e. intrauterine device or hormonal contraceptives for at least three months) or a double barrier contraceptive measure (i.e. condom and spermicidal gel or diaphragm and spermicidal gel for at least 14 days) prior to the start of the study and through the study and for 30 days after completion of the study, or
- Surgically sterilized for at least 6 months or
- Menopausal women, for at least 1 year
排除标准
- The patient is pregnant or nursing (lactating) women, where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive urine or serum pregnancy test.
- The patient has any significant or organ abnormality as determined by the principal investigator/sub-investigator.
- The patient has skin abnormalities/irritations at the potential injection site (right or left deltoid) as determined by the Principal Investigator/clinical Sub-Investigator.
- The patient has a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of paliperidone.
- The patient has known allergy to the Paliperidone Palmitate or to any ingredient in the preparation.
- The patient has a history of hypersensitivity to heparin.
- The patient intended to significantly change the smoking habits during the trial (i.e. planned cessation or start of smoking career).
- The patient will consume alcohol or caffeine or related xanthine containing foods or beverages for 48 hours prior to each dosing.
- The patient will consume grapefruit or pomelo-containing beverages and foods within 7 days prior to each dosing.
- The patient has a history of or current compulsive abuse of alcohol (more than 10 drinks weekly) or regular exposure to other substance of abuse.
- The patient is on a special diet (for example the patient is a vegetarian), or dieting (on a weight lowering plan) during the month before the study.
- The patient participated in a comparative bioavailability/ bioequivalence study within the last 90 days before first dose of period I.
- The patient participated in a clinical study within the last 90 days before first dose of period I.
- The patient donated blood or any of its constituents (1 unit or 350 ml) within the last 90 days before first dose of period I.
- The patient has positive testing for HIV I & II and/or Hepatitis B and/or Hepatitis C using ELISA method.
- The patient has positive test for illicit drugs or alcohol before any dose.
- The patient is suffering from severe hepatic impairment.
- The patient is suffering from renal impairment
- Presence or history of clinically significant cardiovascular disease (especially known history of QT prolongation, congenital long QT syndrome, recent acute myocardial infarction, cardiac arrhythmias, or with uncompensated heart failure).
- The patient is receiving medicinal products known to prolong the QT interval, e.g. class 1 Antiarrhythmics (e.g., quinidine, disopyramide, procainamide) and class III antiarrhythmics (e.g. amiodarone, sotalol), antihistamines, antipsychotics known to prolong QT interval, and antimalarials (e.g. mefloquine, quinine), tricyclic antidepressants (eg amitriptyline), tetracyclic antidepressants (eg maprotiline).
- The patient is receiving centrally acting medicinal products e.g. anxiolytics, risperidone, opiates, etc. or alcohol
- The patient is receiving drugs that induce orthostatic hypotension (e,g other antipsychotics, tricyclic).
- The patient is receiving medicinal products known to lower the seizure threshold (e.g. phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.)
- The patient is receiving carbamazepine (causes decrease in mean steady state Cmax and AUC of Paliperidone)
- The patient has current thoughts of suicide or violent tendencies at screening.
研究组 & 干预措施
Reference treatment
Paliperidone palmitate 156 mg (equivalent to Paliperidone 100 mg) extended release injectable suspension
干预措施: Paliperidone (Drug)
Test treatment
Paliperidone palmitate extended-release injectable suspension for intramuscular use 156 mg (100 mg of Paliperiodne)
干预措施: Paliperidone (Drug)
结局指标
主要结局
Cmax(ss)
时间窗: 28 days
Maximum plasma concentration at steady state
AUC0-τ(ss)
时间窗: 28 days
AUC during a dosage interval at steady state
Cτ(ss)
时间窗: 28 days
Concentration at the end of the dosing interval at steady state
次要结局
- Tmax(ss)(28 days)
- Fluctuation(28 days)
- Cmin(ss)(28 days)
- Number of participants with treatment-related adverse events(281 days)
研究者
研究点 (3)
标识符
- NCT 编号
- NCT03425552
- 其他研究编号
- PAL.100/316
日期
- 首次提交
- (8年前)
- 首次发布
- (8年前)
- 主要完成日期
- (7年前)
- 研究完成日期
- (7年前)
- 最近核实
- 最近更新
- (7年前)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否