Healthy Healthy Volunteer
Conditions
Interventions
Originator Escitalopram Strength 20 mg film-coated tablet,Generic Escitalopram Strength 20 mg film-coated tablet
Active Comparator Drug,Active Comparator Drug
Escitalopram,Escitalopram
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male or female subjects between the ages of 18 to 55 years. 2. Body mass index between 18.0 to 30.0 kg/m2. 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 5. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 14 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 14 days after the end of study in Period 2. 7. Have voluntarily given written informed consents (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction or hypersensitivity to escitalopram or citalopram or to any of the excipients 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. seizure), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 4. History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period. 5. History of suicidal thoughts, behavior or suicide attempts in the past 30 days prior to screening or during enrollment in the study 6. History or evidence of clinically significant active bleeding or bruising 7. History or evidence of diabetes mellitus 8. History or evidence of clinically significant seizure 9. History or evidence of mania or hypomania 10. History or evidence of clinically significant QT interval prolongation or congenital long QT syndrome 11. History or evidence of akathisia 12. History or evidence of clinically significant severe hepatic function 13. History or evidence of clinically significant coronary heart disease 14. History or evidence of angle-closure glaucoma or glaucoma 15. Investigation with blood sample shows level of sodium less than 136 or more than 145 mmol/L at screening laboratory test. 16. History or evidence of clinically significant hyponatremia 17. History of problems with swallowing tablet or capsule 18. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 19. History of sensitivity to heparin or heparin-induced thrombocytopenia 20. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 21. History of vomiting or diarrhea within 24 hours prior to check-in in each period 22. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 23. 12-lead ECG demonstrating QTc more than 450 msec, a QRS interval more than 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject of eligibility. 24. Investigation with blood sample shows positive test for HBsAg 25. Abnormal liver function, more than or equal to 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 26. Has renal creatinine clearance (Clcr) less than 30 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test 27. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study 28. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax at time 0.00 (pre-dose) and at 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 34.00, 48.00 and 72.00 hours post-dose. liquid chromatography-mass spectrometry method ,Truncated AUC0-72 at time 0.00 (pre-dose) and at 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 34.00, 48.00 and 72.00 hours post-dose. liquid chromatography-mass spectrometry method | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax at time 0.00 (pre-dose) and at 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 34.00, 48.00 and 72.00 hours post-dose. liquid chromatography-mass spectrometry method,t1/2 at time 0.00 (pre-dose) and at 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 34.00, 48.00 and 72.00 hours post-dose. liquid chromatography-mass spectrometry method,Elimination rate constant at time 0.00 (pre-dose) and at 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 34.00, 48.00 and 72.00 hours post-dose. liquid chromatography-mass spectrometry method | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed