NCT02295046已完成1 期
Open Label, Randomized, Two-treatment, Two-period, Two-sequence,Crossover, Single Dose, Oral Bioequivalence Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10mg/80mg Under Fasting Condition
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
- 80
- 试验地点
- 1
- 主要终点
- Area under curve (AUC)
研究概览
简要总结
This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland in Healthy Male and Female Volunteers under Fasting conditions.
详细描述
Open label, randomized, two-treatment, two-period, two-sequence, crossover, single dose, oral bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers between 18 and 55 years of age
- •Subject with the Body Mass Index within 18.5 and 24.9 kg/m2, weight not less than 50 kg
- •Normal health as determined by personal medical history, haematology, clinical chemistry and urinalysis laboratory profiles
- •Non smokers or ex-smokers that gave up smoking for at least two years prior to the study
- •The subject agrees to abstain from alcohol, food and drinks containing methylxanthines (tea, cola, chocolate) for 48 hours prior to study drug administration and during each study period and from grapefruit-containing food and beverages for 48 hours prior to study drug administration and during each study period
- •Ability to understand the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Clinical Investigator and to comply with the requirements of the entire study
- •Informed written consent given voluntary before the initiation of the pre-study screening
- •Negative results to the HIV, hepatitis C or hepatitis B test
- •Negative results from pregnancy tests (for female subjects only)
- •Non-lactating woman (for female subjects only)
- •Subjects using non-hormonal contraceptive measures during the study (for female subjects only)
- •Normal creatine phosphokinase (CPK) levels at the time of check-in of each period.
排除标准
- •History of hypersensitivity to the test drug (Amlodipine Besylate/Atorvastatin Calcium) or to drugs belonging to the same pharmacological and chemical class and inactive ingredients of the formulation
- •Participation in a clinical study with an investigational product in the preceding three months or in a clinical study with a generic product in the preceding two months
- •Hospitalization for any reason within eight weeks prior to the study initiation
- •Donation of 450 ml or more of blood, within eight weeks prior to the study initiation
- •Intake of any prescription or non-prescription drug (including anti-acids, analgesics, statins, cyclosporin, fibric acid derivatives, erythromycin, azole antifungals, niacin, oral contraceptives etc.) during the two weeks preceding the study or throughout the study
- •History of presence of any relevant medical condition including cancer, significant disease of the renal, hepatic, immunological, dermatological, gastrointestinal, respiratory, cardiovascular, endocrine or locomotor systems, and any metabolic, haematological neurological disorder or psychiatric disorder
- •History or presence of drug or alcohol abuse, within the past year
- •History or any current condition or other disease known to interfere with the absorption, distribution, metabolism or excretion of investigational medicines
- •ECG having evidence of clinically significant abnormalities
- •Presence of any acute or chronic infectious disease
- •Positive results to the HIV, hepatitis C or hepatitis B tests
- •Positive results to the breath alcohol test and drugs of abuse checks
- •Positive results to the pregnancy tests (for female subjects only)
- •Subject is vegetarian or follows particular diets
- •A history of difficulty with donating blood.
研究组 & 干预措施
Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg
Experimental
Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg of Dr. Reddys Laboratories Limited
干预措施: Amlodipine besylate/Atorvastatin calcium (Drug)
Caduet
Active Comparator
Caduet® 10/80 mg tablets of Pfizer, Ireland
干预措施: Amlodipine besylate/Atorvastatin calcium (Drug)
结局指标
主要结局
Area under curve (AUC)
时间窗: 0.50; 1.00; 2.00; 3.00; 4.00; 5.00; 6.00; 7.00; 8.00; 10.00; 11.00; 12.00 16.00; 24.00; 36.00;48.00 and 72.00 hours post dose for Amlodipine
次要结局
- Area under curve (AUC)(10 min; 20 min; 30 min; 40 min; 50 min; 1.00; 1.25; 1.50; 1.75; 2.00; 2.25; 2.50; 2.75; 3.00; 3.50; 4.00; 4.50; 5.00; 6.00; 8.00; 10.00; 12.00 16.00;24.00; 36.00; 48.00 and 72.00 hours post dose for Atorvastatin)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed ConditionHealthyNCT02292069Dr. Reddy's Laboratories Limited90
已完成
1 期
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed ConditionsHealthyNCT01645410Dr. Reddy's Laboratories Limited71
已完成
4 期
Double Blind Atorvastatin Amlodipine StudyAnginaNCT00159718Pfizer's Upjohn has merged with Mylan to form Viatris Inc.360
尚未招募
不适用
Bioeqivalence study of amlodipine valsartan 10/160 mg tabletBioequivalence study.IRCT20220209053979N5Alborz Darou24
已完成
4 期
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And DyslipidemiaHypertensionHyperlipidemiaNCT00174330Pfizer's Upjohn has merged with Mylan to form Viatris Inc.330