TCTR20170122001终止1 期
Open Label, Randomized, Two-way Crossover, Two-sequence, Two-period, Two-treatment Bioequivalence Study of 10 mg Ezetimibe Tablet Preparations in Healthy Thai Volunteers
International Bio Service Co., Ltd.0 个研究点目标入组 62 人开始时间: 2017年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
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
- •1Healthy Thai male/female subjects between the ages of 18 to 55 years.
- •2Body mass index between 18.0 to 25.0 kg/m2.
- •3Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- •Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- •4Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- •5Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1:
- •â€¢Postmenopausal for at least 1 year or
- •â€¢Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
- •6Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study.
- •7Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
排除标准
- •1History of allergic reaction or hypersensitivity to ezetimibe or to any excipients of tablet
- •2History or evidence of clinically significant renal, hepatic including cholelithiasis, gastrointestinal, hematological, endocrine e.g. thyroid, diabetes etc. pulmonary or respiratory e.g. asthma, cardiovascular, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- •3History or evidence of muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis
- •4History of problems with swallowing tablet
- •5History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •6History of sensitivity to heparin or heparin-induced thrombocytopenia
- •7Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- •8History of preceding diarrhea within 24 hours prior to admission in each period
- •9History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
- •1012-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject’s eligibility.
- •11Investigation with blood sample shows positive test for HBsAg
- •12Creatine kinase (CK) levels > 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test
- •13Abnormal liver function,  1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- •14History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •15History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •16History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •17Consume or drink juice of grapefruit or orange or its supplement/containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •18Use of prescription or nonprescription drugs e.g. paracetamol, erythromycin, ketoconazole, cyclosporine, statins, fibrates etc., herbal medications or supplements e.g. St. John's wort, iron, vitamins or dietary supplements within 14 days prior to admission in Period 1 or during enrollment
- •19Participated in other clinical trials within 90 days prior to admission in Period 1 (except for the subjects who dropout/withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participate
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