TCTR20180619001招募中4 期
Bioequivalence Study of An Open-Label, Randomized, Two-Way Crossover Design with Two-Period, Two-Treatment, Two-Sequence of Test Product Metformin 850 mg Film-Coated Tablets and Reference Product (Glucophage®) in Healthy Thai Volunteers Under Fed
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University0 个研究点目标入组 28 人开始时间: 2018年6月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 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 45 Years（—）
- 性别
- All
入选标准
- •1)Healthy male and female subjects based on medical history and physical examination, aged between 18-45 years.
- •2)Normal or not clinically significant abnormal of clinical laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), AST, ALT, total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count and urinalysis.
- •3)Clinical laboratory result of hepatitis B is negative.
- •4)No clinically significant findings in vital sign measurement.
- •5)Body Mass Index (BMI) between 18.5-25.0 kg/m2 and body weight is not less than 45 kg.
- •6)Nonsmoker or stop smoking for at least 6 months.
- •7)Females who participate in this study must:
- •7.1) be nonpregnant female (negative result for pregnancy test).
- •7.2) commit to use acceptable non-hormonal contraceptive method of birth control for at least 2 weeks before and during the study as judged by the clinical investigators, such as condoms, non-hormonal intrauterine device (IUD), or willing to remain abstinence (not engage in sexual intercourse) , if there is childbearing potential.
- •7.3) be not currently breastfeeding.
- •8) Subjects are able, willing to comply with study procedures and restrictions.
排除标准
- •1)Subjects with a history of allergy to metformin or related structure of metformin or other components in the formulation.
- •2)Subjects who demonstrate allergic-type reaction of biguanide class of hypoglycemic.
- •3)Subjects with currently or history of alcohol addiction or drug abuse.
- •4)Subjects with currently or history of severe asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, arrhythmia, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the medication studied or safety of the subjects.
- •5) Subjects who use any medications including vitamins, herbal products, and dietary supplement, within 14 days before and during the study.
- •6)Subjects who are unable to refrain from consumption of orange, pamelo, grapefruit within 7 days before and during the study.
- •7)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.
- •8)Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates).
- •9)Subjects with positive alcohol breath test.
- •10)Subjects with a history of blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study.
- •11)Subjects who participate in other clinical trials within 90 days before the initiation of the study.
研究者
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