A two-sequence, multiple-dose, crossover study to investigate the effect and safety of the herbal medicine on the pharmacokinetic properties of escitalopram after oral administration in healthy adults
- Conditions
- Not Applicable
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 18
1) Healthy adults aged 19 or over and under 55 years of age at the time of screening
2) Men weigh 55 kg or more, women weigh 50 kg or more
3) Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2
1) Clinically significant hepatobiliary system (severe liver disorders, etc.), kidney (severe renal disorders, etc.), nervous system (serotonin syndrome, etc.), immune system, respiratory system, endocrine system, urinary system, blood/tumor, cardiovascular system (those who have a disease or mental illness (manic, bipolar disorder, depression, etc.) that corresponds to angina pectoris, myocardial infarction, heart failure, etc.
2) Those who have had a history of suicide attempts throughout their lifetime or had suicidal thoughts within 6 months of the first administration of the research drug
3) Those who have a history of gastrointestinal diseases (Crohn's disease, ulcerative colitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of drugs
4) Persons with a history of significant drug hypersensitivity reactions, including ingredients of research drugs (escitalopram, citalopram, etc.)
5) A person who is judged to be unsuitable as a research subject in a screening test conducted within 28 days prior to the first administration of the research drug
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax,ss, AUCtau,ss of escitalopram
- Secondary Outcome Measures
Name Time Method AUCinf,ss, AUClast,ss, Tmax,ss, t1/2, CLss /F, Vd ss/F of escitalopram;Safety;CYP450 polymorphism