None listed
Conditions
Interventions
Drug : Group 1: period1 E >> period2 E+A1 >> period3 E+A2
Group 2: period1 E >> period2 E+A3 >> period3 E+A4
- E:oral administration of Escitalopram 10 mg, single-dose
- E+A1: Escitalopram 10 mg once
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss, AUCtau,ss of escitalopram | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf,ss, AUClast,ss, Tmax,ss, t1/2, CLss /F, Vd ss/F of escitalopram;Safety;CYP450 polymorphism | — |
Countries
Korea, Republic of
Contacts
Public ContactCHOON OK KIM
Yonsei University Health System, Severance Hospital
Outcome results
None listed