Bioequivalence Study of 10 mg Escitalopram Oxalate Film Coated Tablets in Healthy Volunteers

Medifive Pharma Co., Ltd.0 sites24 target enrollmentOctober 25, 2016

Overview

No summary available.

Registry

who.int

Start Date

October 25, 2016

End Date

October 18, 2016

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Medifive Pharma Co., Ltd.

•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)

•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