TCTR20221003003尚未招募1 期
A Bioequivalence Study of Two Formulations of 25-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions
Siriraj Institute of Clinical Research (SICRES)0 个研究点目标入组 28 人开始时间: 2022年10月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 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.Thai male and/or female age between 18-55 years 2.BHas body mass index (BMI) between 18.0-30.0 kg/m2 3.Has been determined healthy by physical examination, assessment of medical history, and vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 129 mmHg, diastolic blood pressure not lower than 60 or not over 79 mmHg), body temperature, pulse rate, respiratory rate) or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians 4.Has normal or acceptable results (being assessed as not clinically significant by the clinical investigator) for all screening tests including: complete blood count (CBC), fasting blood sugar (FBS), aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP), total bilirubin, blood urea nitrogen (BUN), serum creatinine (Cr), Potassium, Sodium, Chloride, Phosphate and urinalysis 5.Has negative result for hepatitis B viral profile (HBsAg) 6.Has normal or acceptable report (being assessed as not clinically significant by the clinical investigator) for EKG 7.Female subject who is childbearing potential and using effective non-hormonal contraceptive methods (e.g., condom, diaphragm, cervical cap or sexual abstinence) or total abstinence from sexual intercourse from screening visit to the follow-up visit. 8.Male subject agrees to use effective contraceptive from screening visit to the follow-up visit. 9.Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)). 10.Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing at screening and prior to dosing at period 1 and period 2. 11.Non-smokers (never smoked or no smoking within the previous 1 year) 12.Refrain from using herbal medications, dietary supplements (e.g., St. John Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period 2. 13.Subjects must have ended the systematic medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow-up period. 14.In case subject have received Coronavirus Disease-19 (COVID-19) vaccine, subjects must have received the COVID-19 vaccine at least 14 days before dosing. 15.Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of period 2. 16.Has ability and intention to comply with the requirement of study and available for the whole study period 17.Willing to participate and voluntarily signed the informed consent form prior to participate the study
排除标准
- •1.Known hypersensitivity to montelukast and/or related structure and/or its constituents. 2.Has history or concurrent symptoms of allergy, cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug. 3.Alcohol abuse or excessive use (more than 1 time/week) in the last 12 months 4.Alcohol breath test at screening visit or before admission show alcohol concentration more than 0 mg%. 5.History of drug abuse or urine sample shows a positive test for Morphine, Marijuana and Methamphetamine. 6.Following a special diet (e.g., vegetarian) or dieting one month before the study initiation. 7.A pregnant woman (positive pregnancy test at screening and/or prior to dosing in each period) and/or woman in breast feeding period 8.A woman of childbearing potential and using hormonal contraceptive methods including oral contraceptives, hormone replacement therapy and transdermal contraceptives within 14 days prior to dosing and during the entire period of the study and/or using injected, intrauterine and implanted hormonal methods of contraception within 3 months prior to dosing and during the entire period of the study 9.A participant in any investigation drug study within last 30 days prior to screening (from the last follow-up visit to the screening) 10.Has blood donated within last 2 months
研究者
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