NCT01082250已完成1 期
AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
详细描述
12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders as per DSM-IV or DSM-IV-TR criteria, which in the opinion of the investigator have been clinically stable for the past 6 months.
- •Body mass index (BMI) ≥ 19.5 and ≤ 37 kg/m
- •No clinically relevant abnormal laboratory values.
- •No clinically significant findings in the 12-lead electrocardiogram (ECG):
- •No clinically significant findings from a vital signs measurement.
- •Able to understand and provide written consent prior to initiating any study procedure after being informed of the nature of the study.
- •Females who participate in this study:
- •are unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy); OR
- •are willing to remain abstinent [not engage in sexual intercourse] from Day -5 until the final follow-up visit; OR
- •are willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide, or intrauterine device [IUD]) from Day -5 until the final follow-up visit.
- •Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until the final follow-up visit.
排除标准
- •Significant disease(s) or clinically significant finding(s) in a physical examination determined by an Investigator to pose a health concern to the patient while on study.
- •Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications).
- •History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry.
- •Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
- •Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
- •A history of epilepsy or risk of having seizures.
- •Positive test results within 30 days prior to the start of the study for:
- •Human immunodeficiency virus (HIV).
- •Hepatitis B surface antigen and Hepatitis C antibody.
- •Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
- •Serum beta-HCG consistent with pregnancy (females only).
- •Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
- •Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to check-in, including but not limited to those listed in Appendix 19.
- •Difficulty fasting or consuming the standard meals.
- •Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
- •OR- Females having used implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
- •Donation or loss of whole blood prior to drug administration, as follows:
- •≤ 499 mL within 30 days prior to dosing
- •≥ 500 mL within 56 days prior to dosing.
- •Patient has a prolactin concentration ≥ 100 ng/mL at Screening.
研究组 & 干预措施
Reference Formulation
Other
Dosed 12.5% drugload 3X40mg
干预措施: Lurasidone HCl (Drug)
Test Formulation
Other
25% Drugload 1X120mg
干预措施: Lurasidone HCl (Drug)
研究者
研究点 (1)
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