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 conditio

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

< 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