NCT00650221已完成1 期
A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions.
Based on the results from this study, the two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects meeting the following criteria may be included in the study:
- •Non-smoking male or female with a minimum age of 18 years.
- •Body Mass Index (BMI = weight/height2) greater than or equal to 19 kg/m2 and less than or equal to 26 kg/m
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
- •Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min and temperature between 35.8°C and 37.5°C).
- •Negative for drugs of abuse, nicotine , alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).
- •No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
- •Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.
排除标准
- •Subjects meeting any of the following criteria will be excluded:
- •Known history of hypersensitivity to pravastatin sodium (e.g. Pravachol®, Lipostat®) and/or related drugs such as simvastatin (Zocor®), atorvastatin (Lipitor™), cerivastatin (Baycol®) or fluvastatin (Lescol®).
- •Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
- •Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Any clinically significant illness during the last four weeks prior to entry into this study.
- •Presence of any significant physical or organ abnormality.
- •Any subject with a history of drug abuse.
- •Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
- •Use of any prescription medication within 14 days preceding entry into this study.
- •Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
- •Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
- •Female subjects: presence of pregnancy or lactation.
- •Any subject who has had blood withdrawals within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
- •Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- •Any subject who has donated blood within 56 days preceding this study.
- •Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
- •Significant or recent history of asthma (after 12 years of age).
- •Any subject with a recent (less than one year) history of alcohol abuse.
研究组 & 干预措施
1
Experimental
干预措施: Pravastatin (Drug)
2
Active Comparator
干预措施: Pravastatin (Drug)
结局指标
主要结局
Bioequivalence
时间窗: Within 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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