KCT0001677已完成未知
Bioequivalence study of aripiprazole when administered as a 15 mg orally disintegrating tablet relative to a 15 mg commercial tablet in healthy male and/or female subjects under fasting condition
BioCore0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 45(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •Inclusion/exclusion criteria
- •< Inclusion criteria >
- •- Subjects who are 45-64 years old at the screening visit
- •- Subjects who do not have hereditary or chronic diseases and, as a result of internal medicine examination
- •(in case necessary, EEG (electroencephalogram), ECG (electrocardiogram), thoracoscope and gastroscope
- •gastrointestinal radiologic study), do not have morbid symptom or diagnosis
- •- Subjects who are judged to be suitable to be qualify the subject from the study as a result of clinical pathologic study
- •such as general blood study, general chemistry study, immune serum study and urine study set and conducted
- •by medical doctor in charge following the characteristic of medicine.
- •- Females must be confirmed to be not pregnant at the screening visit.
- •- Subjects who did not blood donation of the whole blood within the recent 2 months, and did not blood donation of
- •blood component within the recent 2 weeks
排除标准
- •< Exclusion criteria >
- •- Subjects who took drug metabolizing enzyme revulsive and suppressive medicine of barbital drugs
- •(potent inhibitors of the CYP3A4 or CYP2D6 isoenzymes or inducers of drug metabolizing enzymes) or
- •have excessive drinking (alcohol) within 1 month before initiating the study
- •- Subjects who took the drugs which have concerns of interference with this study within 10 days before
- •initiating the study
- •- Subjects who are judged to be not suitable for this bioequivalence study by the medical doctor in charge
- •- Subjects who have experience in participating in bioequivalence study or other clinical study within 3 months
- •before conducting this study
- •- Subjects who are known to have hypersensitivity to this drug
- •- Subjects who have hereditary problems such as galactose intolerance, Lapp lactase deficiency or
- •glucose-galactose malabsorption
- •- In case the participant is a woman, Breast-feeding or women of childbearing potential who cannot or
- •will not use effective contraceptive measure Female subjects of childbearing potential have a positive urine
- •pregnancy test at the screening visit and positive urine testing at baseline visit. Females are not postmenopausal
- •for at least 1 year prior to screening visit, fertile by surgery/operation, or do not use an acceptable method of birth
- •control (intrauterine contraceptive device [Loop, Mirena], double birth control method
- •[diaphragm or condom/femidom + spermicides], oral contraceptives and non-oral contraceptives) effectively.
- •(Abstinence is not an acceptable method of contraception for the study.)
- •The subjects who do not consent to use an appropriate contraception for the duration of the study and for
- •12 weeks after the last dose of the investigational product.
- •-For male subjects, the subjects or their female partners do not agree to use an adequate method of contraception
- •throughout the participation in the study and for 12 weeks after last dose of the investigational product.
- •- Subjects who have family history and anamnesis about muscle tone abnormal response
- •- Subjects who have depression or other psychiatric history
研究者
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