TCTR20230208001Unknown1 期
An Open Label, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Oral Dose, Crossover BE Study of EXITIN (10 mg) of the Government Pharmaceutical Organization, Thailand with Lexapro of H.LUNDBECK A/S, Denmark in Normal, Healthy, Adult Human Subjects under Fasting Conditions
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Normal, healthy, adult, both males and females subjects between 18 and 55 years of age (both inclusive).
- •2.Having a Body Mass Index (BMI) between 18.0 and 30.0 (both inclusive), calculated as weight in kg/height in m2.
- •3.Subject whose clinical laboratory values are within normal/acceptable reference ranges or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. If any subject has values outside of the pre-defined normal/acceptable range, the study physician/ Principal Investigator should have a clearly documented and medically rigorous justification for making that exception.
- •4.Normal medical history, clinical examination, 12 lead ECG, and chest X-ray recordings (during the last 6 months) (postero-anterior view).
- •5.Able to understand and comply with the study procedures, in the opinion of the investigator.
- •6.Able to give voluntary written informed consent for participation in the trial.
- •7.In case of female subjects:
- •- Surgically sterilized at least 06 months prior to study participation;
- •- If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- •- Urine pregnancy test must be negative.
排除标准
- •1)Known hypersensitivity to escitalopram or any excipients or any related drug or any substance.
- •2)History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •3)Subjects who are being or have previously been treated for any GI problems or convulsive, depressive or hepatic disorders, and in whom there is a risk of a recurrence during the study period.
- •4)Ingestion or use of any medication [prescribed medication & over the counter (OTC) medication including herbal remedies and St. John Wort] at any time in 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- •5)Any history of bronchospasm, asthma, urticaria or other allergic type reactions after taking any medication.
- •6)Consumption of grapefruits and grapefruit products within a period of 72 hours prior to dosing in Period-I.
- •7)Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks) 24 hours prior to IMP administration of period-I.
- •8)Heavy smoking (greater than or equal to 10 cigarettes/day).
- •9)Moderate smoking (greater than 10 cigarettes/day) and consumption of tobacco containing products, which cannot stop smoking or consuming 24 hours prior to dosing and for entire duration of the study.
- •10)A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period-I.
- •11)The presence of clinically significant abnormal laboratory values during screening.
- •12)Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
- •13)History or presence of seizure or psychiatric disorder.
- •14)A history of difficulty with donating blood.
- •15)Difficulty in swallowing solids dosage forms like tablets or capsules.
- •16)Donation of blood (1 unit or 350 mL) within a period of 30 days prior to the first dose of study medication.
- •17)Receipt of an investigational medicinal product or participation in a drug research study within a period of 30 days prior to the first dose of study medication**.
- •** If investigational medicinal product is received within 30 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- •18)A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •19)A positive test result for HIV.
- •20)A positive result for COVID-19 rapid antigen test through the nasopharyngeal swab (Antigen test kit, ATK).
- •21)An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- •22)Nursing mothers (for female subjects).
- •23)History or presence of QT prolongation.
- •24)History or presence of suicide attempt or panic disorder or mania/hypomania or depression.
研究者
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