NCT00549666已完成1 期
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
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
- 23
- 试验地点
- 1
研究概览
简要总结
A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is female between 18 and 40 years of age
- •Female subjects of reproductive potential will demonstrate a negative serum β-human chorionic gonadotropin level consistent with the non-gravid state at the screening visit
- •Subject agrees to take the triphasic oral contraceptive, Ortho Tri-Cyclen™, throughout the study.
- •Subject has a history of regular menstrual periods with no substantial breakthrough bleeding episodes while taking Ortho Tri-Cyclen™.
- •Subject has a body mass index that is < 33 kg/m2 (see Appendix 1).
- •Subject is judged to be in good health
- •Subject must have a negative hepatiti and HIV antibody at screening.
- •Subject has no clinically significant abnormality on screening ECG.
排除标准
- •Subject has a history of major GI abnormalities/peptic ulceration, hematological, genitourinary, cardiovascular (including hypertension), renal, hepatic, pulmonary, psychiatric, endocrine (including diabetes) or metabolic (including glaucoma), neurologic or cerebrovascular disease, or any history of cancer.
- •Subject has systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at screening.
- •Subject has a history of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any gastrointestinal surgery.
- •Subject has any other acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would limit the patient safety or confound the results of the study.
- •Subject has an ECG at screening with PR > 240 msec; QRS complex > 120 msec; QTcB > 450; or any significant morphologic changes other than nonspecific T-wave changes.
- •Subject is currently a user of any illicit drugs (including "recreational use") including marijuana, or has recently used illicit drugs, or has a history of drug or alcohol dependence in the past year or abuse within the last 3 months.
- •Subject consumes excessive amounts of alcohol
- •Subject has had surgery within last 12 weeks, donated a unit of blood (within 4 weeks), or participated in another clinical study within 30 days of screening.
- •Subjects with hypertension, hyperlipidemia, and diabetes should also be excluded. (See package circular under "Contraindications")
- •Subject has clinically significant abnormalities at screening clinical examination or laboratory safety tests
- •Subject has a prolactin level of over 200 ng/mL at screening.
研究组 & 干预措施
Lurasidone 40 mg
Experimental
干预措施: Lurasidone 40 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo 40 mg (Drug)
Ortho Tri-Cyclen
Active Comparator
干预措施: Ortho Tri-Cyclen (Drug)
研究者
研究点 (1)
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