Healthy volunteers
Conditions
Interventions
Subjects will receive escitalopram oxalate 10 mg reference product in treatment period 1. After 3 weeks washout period,
subjects will crossover to receive escitalopram oxalate 10 mg test product in treatment period 2.,Subjects will receive escitalopram oxalate 10 mg test product in treatment period 1. After 3 weeks was
subjects will crossover to receive escitalopram oxalate 10 mg reference product in treatment period 2.
Active Comparator Drug,Active Comparator Drug
Escitalopram sequence RT,Escitalopram sequence TR
Sponsors
Medifive Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Male and female subjects age between 18-45 years 2) Body Mass Index (BMI) between 18.5-25.0 kg/m2 and body weight not less than 45 kg 3) Healthy subjects based on medical history and physical examination 4) Normal or not clinically significant abnormal of clinical laboratory results including blood urea nitrogen (BUN), serum creatinine, AST, ALT, total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, serum sodium, complete blood count and urinalysis 5) Clinical laboratory result of hepatitis B is negative. 6) No clinically significant findings in vital sign measurement 7) No clinically significant findings of QT prolonged in electrocardiogram (EKG) or other related abnormality 8) Non smoker or stop smoking for at least 6 months 9) Females who participate in this study are: 9.1) Non pregnant female (negative result for pregnancy test) 9.2) Unable to have children (e.g. tubal ligation, hysterectomy, being postmenopausal at least 1 year before the enrollment) or 9.3) With childbearing potential, whom must commit to using acceptable non-hormonal contraceptive method of birth control for at least 2 weeks before and during the study as judged by the clinical investigators, such as condoms, non hormonal intrauterine device (IUD), or willing to remain abstinence (not engage in sexual intercourse) or 9.4) Not currently breast feeding 10) Subjects are able, willing, and likely to comply with study procedures and restrictions
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of allergy to escitalopram or related structure of escitalopram or other components in the formulation 2) Subjects with currently or history of alcohol addiction or drug abuse 3) Subjects with currently or history of severe asthma, lung disease, seizures, stomach bleeding or ulcer, heart rhythm problem, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the medication or safety of the subjects 4) Subjects who use of any medication (especially the drug which inhibited CYP2C19 and CYP3A4), including vitamins, herbal products, and dietary supplement, within 14 days before and during the study 5) Subjects who are unable to refrain from consumption of orange, pamelo, grapefruit within 7 days before and during the study 6) Subjects who are unable to refrain from caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before and during the study 7) Subjects with a history of blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study 8) Subjects who participate in other clinical trials within 90 days before the initiation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Escitalopram 0, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 LC-MS/MS,Area Under the Plasma Concentration Time Curve From 0-tlast (AUC0-t) of Escitalopram 0, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 LC-MS/MS,Area Under the Plasma Concentration Time Curve From 0-72 h (AUC0-72) of Escitalopram 0, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 LC-MS/MS | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A N/A N/A | — |
Countries
Thailand
Contacts
Public ContactWandee Taesotikul
Faculty of Pharmacy, Chiang Mai University
Outcome results
None listed