CTRI/2011/05/001761Other2 期
Comparative Assessment of Tolerability, Efficacy and Safety of Combination of Compound CDRI 80/574 and Atorvastatin versus Atorvastatin in subjects with Hyperlipidemia (A Randomized, Double-blind, Parallel-group, Active-comparator Controlled, Phase II Clinical Study) - Nil
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 56
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
入选标准
- •1.Healthy volunteers
- •2.18-45 years of age
- •3.Either sex
- •4.Willing to give written informed consent
排除标准
- •1.Known hypersensitivity or intolerance to the study drugs
- •2.Pregnant or lactating women
- •3.HIV positive subjects
- •4.Presence of liver disease: Serum bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5 times the upper limit of normal (ULN)
- •5.Presence of kidney disease: Serum Creatinine 1.5 times the ULN
- •6.Subjects with abnormal hematologic function (Hemoglobin ¡Ü 8gm/dl, WBC count ¡Ü3000/mm3, platelet count ¡Ü100,000/mm3).
- •7.Presence of systemic diseases such as seizure disorder, diabetes mellitus, congestive heart failure or malignancy
- •8.Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy will be excluded.
- •9.Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- •10.Resting heart rate of 100 beats/min or 60 beats/min on the screening day.
- •11.History of hypotensive episodes, or systolic blood pressure reading of 100 mm Hg or a diastolic reading of 60 mm Hg at time of general physical examination.
- •12.History of hypertension, or systolic blood pressure reading of 139 mm Hg or a diastolic reading 89 mm Hg at time of general physical examination.
- •13.Subject who have taken over the counter or prescribed medications, including any enzymes modifying drugs or any systemic medication within the past four weeks prior to start of clinical period.
- •14.Subjects receiving lipid-lowering therapy during 4 weeks preceding enrollment
- •15.Chronic alcoholic or drug abuse subjects
- •16.Heavy smokers (smoking 10 cigarettes/biddies/day) or mild to moderate smokers (smoking 10 cigarettes/biddies/day) who are not willing to discontinue smoking 48 hours before initiation of study and during the study period.
- •17.Subject who participated in any other clinical investigation using an experimental drug or have donated blood or had more than 300ml of blood drawn in the past 3 months.
- •18.Subject without adequate venous access to allow collection of all samples via venous cannula during the study.
- •19.Subjects unwilling or unable to comply with the study procedures.
研究者
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