Bioequivalence Study Healthy Thai Volunteers Bioequivalence Study Healthy Thai Volunteers
Conditions
Interventions
AESCITAM 20 MG, Each film-coated tablet contains escitalopram oxalate equivalent to escitalopram 20 mg.
,Lexapro 20 mg, Reg. No. 1C 61/46 (NC), manufactured by H.Lundbeck Co., Ltd., Denmark and impor
Active Comparator Drug,Active Comparator Drug
Test (T) :Generic escitalopram 20 mg film-coated tablet, AESCITAM 20 MG,Reference (R): Escitalopram 20 mg film-coated tablet, Lexapro 20 mg
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 orhysterectomy) 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, on the day of check-in or at the end of the study in each study period 6History or evidence of clinically significant active bleeding or bruis 7.History or evidence of diabetes mellitus 8.History or evidence of clinically significant seizure 9.History or evidence of mania or hypomania 10History or evidence of clinically significant QT interval prolongation or congenital long QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Escitalopram Plasma concentration 0-72 hrs, 19 points, 2 ambulatory visits (48,72 hrs) Cmax and Truncated AUC0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Escitalopram Plasma concentration 0-72 hrs, 19 points, 2 ambulatory visits (48,72 hrs) Tmax, t1/2 | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co.,Ltd.
Outcome results
None listed