TCTR20200806001已完成4 期
A Single Dose, Randomized, Open-label, Two-way CrossoverBioequivalence Study of Generic Atorvastatin 80 mg Film-coated Tablet and Reference Product (LIPITORTM) in Healthy Thai Volunteers under Fasting Condition
Millimed Co., Ltd. (Branch)0 个研究点目标入组 80 人开始时间: 2020年8月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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. Healthy Thai male or female subjects between the ages of 18 to 55 years.
- •2. Body mass index between 18.0 to 30.0 kg/m2.
- •3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening
- •4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- •5. Female 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 check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in 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 check-in in Period 1 until 14 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1.
- •6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
- •7. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
排除标准
- •1. History of allergic reaction or hypersensitivity to atorvastatin or any of the excipients of the product.
- •2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness.
- •3. History or evidence of muscle disease e.g. myalgia, myopathy, muscle weakness, muscle tenderness or rhabdomyolysis.
- •4. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •5. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- •6. History of problems with swallowing tablet or capsule
- •7. History of sensitivity to heparin or heparin-induced thrombocytopenia
- •8. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- •9. History of vomiting or diarrhea within 24 hours prior to check-in in each period
- •10. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
- •11. 12-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.
- •12. Investigation with blood sample shows positive test for HBsAg.
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