NCT01673997已完成1 期
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metoprolol Succinate Extended-Release Tablets 200mg of Dr. Reddy's Laboratories Limited, India Comparing With That of TOPROL-XL® (Containing Metoprolol Succinate) Extended-Release Tablets 200mg of AstraZeneca LP Wilmington, DE in Healthy, Adult, Human Subjects Under Fasting Conditions
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
- 48
- 试验地点
- 1
- 主要终点
- Area under curve (AUC)
研究概览
简要总结
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 200 mg under fasting conditions
详细描述
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 200mg of Dr. Reddy's Laboratories Limited,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 45 Years（Adult）
- 接受健康志愿者
- 是
入选标准
- •Subjects were selected based on the following inclusion criteria:
- •Provide written informed consent.
- •Must be healthy, adult, human beings between 18 and 45 years of age(both inclusive) weighing at least 50 kg.
- •Having a body mass index between 18.5 and 24.9 (both inclusive),calculated as weight in Kg/height in m2
- •Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study.(Laboratory values must be within normal limits or considered by the physician/investigator to be of no clinical significance).
- •Female Subjects of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s),such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- •surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
排除标准
- •The subjects were excluded based on the following criteria during screening and during the study:
- •Incapable of understanding the informed consent.
- •Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
- •Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
- •Oral temperature is below 95.0°F or above 98.6°F.
- •Pulse rate below 50/min or above 100/min.
- •History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
- •Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- •Consumption of grapefruit for the past ten days prior to the check-in, in each period.
- •Habit of tobacco chewing.
- •Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
- •Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
- •Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
- •Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
- •Clinically significant abnormalities and lor with significant diseases.
- •Confirmed positive in alcohol screening.
- •Confirmed positive in selected drug of abuse.
- •Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
- •Confirmed positive in urine pregnancy test.
- •Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
研究组 & 干预措施
Metoprolol Succinate ER Tablets, 200 mg
Experimental
Metoprolol Succinate ER Tablets, 200 mg of Dr.Reddy's Laboratories Ltd
干预措施: Metoprolol Succinate (Drug)
TOPROL-XL ER Tablets 200 mg
Active Comparator
TOPROL-XL ER Tablets 200 mg of AstraZeneca
干预措施: Metoprolol Succinate (Drug)
结局指标
主要结局
Area under curve (AUC)
时间窗: Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting ConditionHealthyNCT01694797Dr. Reddy's Laboratories Limited48
Unknown
1 期
Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult SubjectsHealthyNCT02622230Xinjiang Uygur Pharmaceutical Co., Ltd.60
已完成
1 期
Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy AdultsType 2 Diabetes MellitusNCT01042106Sumitomo Pharma America, Inc.40
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese ParticipantsHealthy VolunteersNCT04965402Bristol-Myers Squibb23
招募中
1 期
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HGR4113 in Healthy SubjectsDiabetes Mellitus, Type 2NCT05642377Glaceum40