TCTR20220209004尚未招募1 期
A randomized, open label, balanced, single-dose, two-formulation, two-sequence, two-period, two-way crossover oral bioequivalence study of test product of Empagliflozin 25 mg Tablets and Jardiance (Empagliflozin 25 mg Tablets) in healthy, adult Thai volunteers under fasting conditions
ovartis (Thailand) Ltd.0 个研究点目标入组 32 人开始时间: 2022年2月9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
- 32
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/Female must be 18-55 years of age, body mass index (BMI) = 18.0-30.0 kg/m2, inclusive.
- •2.Must be in good health as determined by medical history, 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) and physical examination or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians
- •3.Screening electrocardiogram (ECG) without clinically significant abnormalities
- •4.Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), creatinine (Cr), and liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and alkaline phosphatase (ALP)) must be within the normal range or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians.
- •5.Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians.
- •6.Must have serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus antibody (anti-HIV) seronegative
- •7.Female subjects must have beta-subunit of human chorionic gonadotropin (Beta-HCG) in serum negative.
- •8.Female subject who is childbearing potential or male subject agrees to use an acceptable birth control method from visit 1 to the follow-up visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow-up visit. Hormonal contraceptives are not acceptable, except stop usage more than 6 months prior to screening.
- •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 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 any herbal medications, dietary supplements (e.g., St. John s Wort, ginkgo biloba, garlic supplements), vitamins and minerals within 14 days before the first administration of investigational product (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period 2
- •13.Refrain from grapefruit (Pomelo, Sevillia orange etc.) and/or juice, dietary items that have effect on P450 enzymes (e.g. pomegranate, star fruit, seville oranges) & P-GP efflux pump (e.g. St. John s wort) within 14 days before the first administration of investigational product (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period 2.
- •14.Subjects must have ended any medications (including prescribed medication or over-the-counter (OTC) medication) at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow-up period.
- •15.Subject does not receive Coronavirus Disease-19 (COVID-19) vaccine within 14 days before scr
排除标准
- •1.Known hypersensitivity to empagliflozin, any other similar class of drugs or its components
- •2.Past medical history of renal and hepatic insufficiency
- •3.Subject has a history of any illness less than 28 days prior dosing that, in the opinion of principal investigator or designated physicians might confound the result of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
- •4.Have history of drug abuse (in the opinion of principal investigator or designated physicians, as judged by medical history) in the last 12 months
- •5.Have positive result of urine drug abuse testing on opioids (morphine (Mor), methadone (MTD)), cannabinoids (tetrahydrocannabinol (THC)), methamphetamine (Meth), cocaine (Coc) and methylenedioxy-methamphetamine (MDMA) at screening visit or before dose administration at each period
- •6.Alcohol abuse or excessive use (in the opinion of principal investigator or designated physicians, as judged by medical history) in the last 12 months
- •7.Have positive result of alcohol breathing test at screening visit or before dose administration at each period
- •8.Female subject is pregnant or breast feeding.
- •9.Intolerance to direct venipuncture
- •10.Intolerance to lactose, fructose, galactose
- •11.Difficulties fasting or consuming standard meals
- •12.Difficulties swallowing whole tablets
- •13.Donation or loss of whole blood:
- •a.at least 50 mL and equal to or less than 499 mL within 30 days prior to dosing
- •b.at least 500 mL within 56 days prior to dosing
- •14.Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening visit)
研究者
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