TCTR20171229005尚未招募1 期
An Open-label, Single-dose, Two-period, Two-treatment, Two-sequence, Randomized, Crossover Bioequivalence Study of 160 mg Valsartan Tablets between Test Product and Reference Product (Diovan® 160 mg) in Healthy Thai Volunteers under Fasting Conditio
Siriraj Clinical Research Center0 个研究点目标入组 60 人开始时间: 2017年12月29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
- 60
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.Has body mass index (BMI) between 18.0-25.0 kg/m2
- •3.Has been determined healthy by physical examination, assessment of drug abuse, medical history, and vital signs
- •4.Has sitting SBP of 90-140 mmHg and DBP of 60-90 mmHg or acceptable value (being assessed as clinically non-significant by the clinical investigator) at baseline
- •5.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 (K+) and urinalysis
- •6.Has negative result for hepatitis B viral profile (HBsAg)
- •7.Has normal or acceptable report (being assessed as not clinically significant by the clinical investigator) for EKG
- •8.A woman of childbearing potential and using effective non-hormonal contraceptive methods (e.g., condom, diaphragm, cervical cap or sexual abstinence) for at least 14 days prior to the first dosing and entire the participation period.
- •9.A man using effective contraceptive after the first dosing and entire the participation period.
- •10.Has ability and intention to comply with the requirement of study and available for the whole study period
- •11.Willing to participate and voluntarily signed the informed consent form prior to participate the study
排除标准
- •1.History of allergic reaction to valsartan and/or angiotensin II receptor antagonist derivatives (e.g., losartan) 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.Regularly alcohol consumption (more than 1 time/week) and cannot abstain for at least 3 days prior to dosing.
- •4.Alcohol breath test before admission show alcohol concentration more than 0 mg%.
- •5.A smoker (smoking within 30 days before screening)
- •6.History of drug abuse in the last 12 months or urine sample shows a positive test for methamphetamine (Meth), morphine (Mor), tetrahydrocannabinol (THC), cocaine (Coc) and methylenedioxide methamphetamine (MDMA).
- •7.Use of any drugs (except paracetamol) especially which can affect cytochrome P450 enzymes (enzyme inducers e.g., phenobarbital, phenytoin, rifampicin and/or enzyme inhibitors e.g., cimetidine, ketoconazole, erythromycin) within 14 days prior to the first dosing and willing to taking them until after the last sample of the second period is collected.
- •8.Use of paracetamol within 3 days prior to dosing and until after the last sample is collected in each period (Paracetamol taken during this prohibition period can be approved under the consideration of principal investigator or clinical investigator)
- •9.Use of food supplements, vitamins, minerals and/or herbal remedies within 14 days before the first dosing and willing to taking them until after the last sample of the second period is collected.
- •10.Has drink containing xanthine derivatives or xanthine-related compounds (e.g. coffee, tea, colas, chocolate, caffeine-containing sodas and decaffeinated products) within 3 days prior to dosing and until after the last sample is collected in each period.
- •11.Has drink or food containing grapefruit and/or orange and/or pomegranate compound within 3 days prior to dosing and until after the last sample is collected in each period.
- •12.Following a special diet (e.g., vegetarian) or dieting one month before the study initiation.
- •13.A pregnant woman (positive pregnancy test at screening and/or prior to dosing in each period) and/or woman in breast feeding period
- •14.A woman of childbearing potential and using hormonal contraceptive methods including oral contraceptives, hormone replacement therapy and transdermal contraceptives within 14 days prior to the first dosing and until after the last sample of the second period is collected and/or using injected, intrauterine and implanted hormonal methods of contraception within 3 months prior to the first dosing and until after the last sample of the second period is collected.
- •15.A participant in other clinical studies within last 30 days
- •16.Has blood donated and/or blood loss more than 350 mL within last 90 days
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