TCTR20180831003尚未招募1 期
An Open-label, Single-dose, Two-treatment, Two-period, Two-sequence, Randomized, Crossover Bioequivalence Study of 300 mg Irbesartan Tablets between Test and Reference Product (Aprovel® 300 mg) in Healthy Thai Volunteers under Fasting Condition
Siriraj Clinical Research Center0 个研究点目标入组 28 人开始时间: 2018年8月31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.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 (being assessed as clinically non-significant by the clinical investigator)
- •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 non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)) or 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 dosing, during the entire period of the study and continue until 7 days after dosing of period 2
- •9.A man using effective contraceptive after dosing and continue until 7 days after dosing of period 2
- •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 irbesartan and/or angiotensin II receptor antagonist derivatives (e.g., losartan) and/or its constituents.
- •2.Has history or concurrent symptoms of cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug, in the opinion of investigator.
- •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 or urine sample shows a positive test for Methamphetamine, Morphine, Tetrahydrocannabinol, Cocaine or Methylenedioxy-methamphetamine.
- •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 dosing and willing to taking them throughout participation period
- •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 and/or herbal remedies within 14 days before dosing and willing to taking them throughout participation period
- •10.Has drink or food 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 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
- •15.A participant in other clinical studies within last 30 days prior to participate the study.
- •16.Has blood donated and/or blood loss more than 350 mL within last 90 days
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