An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg of Ipca Laboratories Limited, India and 'Toprol-XL®' (Metoprolol Succinate) Extended Release Tablets 50 mg of Astrazeneca LP, USA In Healthy Adult Human Subjects Under Fasting Conditions
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
- Bioequivalence is based on Cmax and AUC parameters.
研究概览
简要总结
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
详细描述
Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 50 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 50 mg of Astrazenica LP, USA under fasting condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 50 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
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）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 45 years old, both inclusive.
- •Sex: Males and/or non-pregnant, non-lactating females.
- •BMI: 18.5 to 24.9 weight in kg/(height in meter)2 both inclusive;
- •Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
- •Able to give written informed consent to participate in the study.
- •All volunteers must be judged by the principal or co-investigator or physician as normal and healthy during a pre-study safety assessment performed within 21 days of the first dose of study medication which will include:
- •A physical examination with no clinically significant finding.
- •Results within normal limits or clinically non-significant for the tests mentioned in List of Laboratory Parameters:
- •Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion.
- •All results will be assessed against the laboratory normal ranges current at the time of testing and a copy of the normal ranges used will be included in the study documentation.
排除标准
- •History of allergic responses to Metoprolol Succinate or other related drugs, or any of its formulation ingredients.
- •Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) & transvaginal ultrasonography (for female volunteers)].
- •Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •History or presence of bronchial asthma.
- •Use of any hormone replacement therapy within 3 months prior to study medication dosing.
- •A depot injection or implant of any drug within 3 months prior to administration of study medication.
- •Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •History of allergic response to heparin.
- •A positive hepatitis screen (includes subtypes B & C).
- •A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- •Volunteers who have donated blood (1 unit or 450 mL) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study, (≤100 mL within 30 days; ≤200 mL within 60 days; >200 mL within 90 days) prior to initial dose of study drug.
- •History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.
- •Intolerance to venipuncture
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteer's participation in this study.
- •Volunteers who have received a known investigational drug within five elimination half life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater.
- •Found positive in urine test for drugs of abuse done before check-in of period I.
研究组 & 干预措施
'TOPROL-XL®' ER Tablets 50 mg
'TOPROL-XL®' ER Tablets 50 mg of Astrazeneca LP, USA
干预措施: Metoprolol Succinate ER Tablets 50 mg (Drug)
'TOPROL-XL®' ER Tablets 50 mg
'TOPROL-XL®' ER Tablets 50 mg of Astrazeneca LP, USA
干预措施: 'TOPROL-XL®' ER Tablets 50 mg (Drug)
Metoprolol Succinate ER Tablets 50 mg
Metoprolol Succinate ER Tablets 50 mg of Ipca Laboratories Limited, India
干预措施: Metoprolol Succinate ER Tablets 50 mg (Drug)
Metoprolol Succinate ER Tablets 50 mg
Metoprolol Succinate ER Tablets 50 mg of Ipca Laboratories Limited, India
干预措施: 'TOPROL-XL®' ER Tablets 50 mg (Drug)
结局指标
主要结局
Bioequivalence is based on Cmax and AUC parameters.
时间窗: 3 Months
Area Under Curve (AUC)and Cmax Sampling Hours: Pre-dose and at 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0,11.0, 12.0, 13.0, 14.0, 16.0, 20.0, 24.0, 36.0 and 48.0 hours post dose.
次要结局
未报告次要终点