NCT00864435已完成1 期
A Two-Way Crossover, Open-Label, Single Dose, Fasting, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 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
- 发起方
- Actavis Inc.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate and Extend of Absorption
研究概览
简要总结
To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fasting conditions.
详细描述
Study Type: Interventional Study Design: Two-way crossover, randomized, open-label, single-dose, fasting, bioequivalence study
Official Title: A Two-Way Crossover, Open-Label, Single Dose, Fasting, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 mg Tablets in Normal, Healthy, Non-Smoking Male and Female Subjects
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Non-smoking male or female with a minimum age of 18 years.
- •Body Mass Index (BMI = weight/heigh2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2
- •Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 106-140/66-90 mmHg, heart rate between 60-99 beats/minute, temperature between 35.8°C and 37.5°C)
- •Negative for drugs of abuse and nicotine.
- •Negative for hepatitis B-surface antigen, hepatitis C and HIV.
- •Female subjects: negative for pregnancy (as evaluated by serum ß-CG test).
- •No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides that they are not clinically significant.
- •Female subjects who were surgically sterile for at least 6 months or post-menopausal for at least 1 year, or avoided pregnancy for at least 10 days before the study, during the study and up until 1 month after the end of the study.
- •Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF
排除标准
- •Known history of hypersensitivity to carvedilol (e.g. Coreg®) and/or related beta¬blockers such as propranolol (Inderal®, nadolol (Corgard®), labetalol (Trandate®, metoprolol (Lopressor®, Betaloc®, atenolol (Tenormin®, sotalol, timolol, pindolol, or acebutolol.
- •Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
- •Presence of any significant physical or organ abnormality.
- •Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
- •Known history of frequent headaches or migraines.
- •Known history of chronic bronchitis or any bronchospastic condition.
- •Any clinically significant illness during the 4 weeks before this study.
- •Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
- •Significant or recent history of asthma (after 12 years of age).
- •Any subject with a history of drug abuse.
- •Any subject with a recent (less than 1 year) history of alcohol abuse.
- •Use of any prescription medication within 14 days preceding this study.
- •Use of any over-the-counter (OTC) cough and cold medication containing dextromethorphan within 14 days preceding this study.
- •Use of OTC medication within 7 days preceding this study (except for spermicidal/barrier contraceptive products).
- •Female subjects: use of contraceptives (oral, emergency [plan B®, transdermal, implant, Mirena® IUD, NuvaRing®) within 30 days before drug administration or a depot injection of progestogen drug (e.g. Depo-Provera® within 1 year before drug administration.
- •Female subjects: evidence of pregnancy or lactation.
- •Any subject who had blood drawn within 56 days preceding this study, 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.
- •Participated in a clinical trial with an investigational drug within 30 days preceding this study.
- •Any subject who had donated blood within 56 days preceding this study.
- •Any subject who had participated as a plasma donor in a plasmapheresis program within 7 days preceding this study.
- •Intolerance to venipuncture.
研究组 & 干预措施
A
Experimental
Carvedilol 12.5 mg Tablets, single dose
干预措施: Carvedilol 12.5 mg Tablets, single dose (Drug)
B
Active Comparator
Coreg® 12.5 mg Tablets , single dose
干预措施: Coreg® 12.5 mg Tablets , single dose (Drug)
结局指标
主要结局
Rate and Extend of Absorption
时间窗: 36 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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