TCTR20170614004尚未招募1 期
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Rosuvastatin 20 mg Film-coated Tablets (ROVISTA, GETZ Pharma (PVT.) Ltd., Pakistan) and Reference product (CRESOR, IPR Pharmaceuticals Inc., Puerto Rico) in Heal
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
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/female subjects between the ages of 18 to 55 years
- •2.Body mass index between 18.0-25.0 kg/m2
- •3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests
- •4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding
- •5.Female subjects abstain from either hormonal method of contraception or hormone replacement therapy for at least 28 days prior to admission in period 1
- •6.Male 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
- •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 rosuvasatin or related structure or any of the component of the formulation
- •2.History or evidence of clinically significant renal, heptatic, gastrointestinal hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric disorder, neurologic or allergic disease or any significant ongoing chronic medical illness
- •3. History of muscular disease or hereditary muscular disorders or history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
- •4.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •5.History of problems with swallowing tablet
- •6.History of sensitivity to heparin or heparin-induced thrombocytopenia
- •7.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- •8.History of preceding diarrhea within 24 hrs prior to admission in each period
- •9.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
- •10.12-lead ECG demonstrating QTc>450 msec, a QRS interval > 120 msec or with an abnormality considered clinically significant at screenign
- •11.Investigation with blood sample shows positive test for HBsAg.
- •12.Abnormal liver function, >=1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- •13.Creatine kinase levels >=1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test
- •14.Renal creatinine clearance (CLcr) <30 mL/min based on serum creatinince results at the screening laboratory test
- •15.History or evidence of habitual use of tobacco or nicotine containing products
- •16.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products
- •17.History evidence of habitual consume of tea, coffee, xanthine or caffeine containing products
- •18.Consumption of grapefruit juice/orange/pomegranate/ its supplement/containing products
- •19.Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole, etc.), herbal medications or supplements, vitamins, mineral or dietary supplements within 14 days prior to admission in Period 1 or during enrollment
- •20. Participated in other clinical trial within 90 days or ongoing long-term clinical trial prior to admission in Period 1 (except for the subjects who dropped out/withdrawn from the previous study prior to Period 1 dosing) or during enrollment
- •21.Blood donation or blood loss> 1 unit (1 unit=350-450 mL of blood) within 90 days prior to admission in Period 1 or during enrollment
- •22. Subjects with poor venous access or intolerant to venepuncture
- •23. Unwilling or unable to comply with scheduled visits, treatment plan and other study procedures until end of study
- •24.Inability to communicate wel that may impair the ability to provide written informed consent or cooperate with clinical team
- •25.Subject who are employees of International Bio Service Co. Ltd., Getz Pharma International FZ LLC, Getz Pharma (PVT.) Ltd. or LF Asia (Thailand) Limited
- •remark: Criteria for habitual use or regular beverage or regular smoke consumption will be followed SOPs of CRD.
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