CTRI/2026/01/102382已完成不适用
A Randomized Open Label Balanced Two Treatment Two Period Two Sequence Single Dose Crossover Oral Bioequivalence Study of Dapagliflozin 10 mg Metoprolol Succinate 25 mg Sustained Release Fixed Dose Combination Tablets Test Product T Dapagliflozin 10 mg and Metoprolol Succinate SR 25 mg Tablet Manufactured by Eris Lifesciences Limited India with Reference Product R Dapaglyn MX 25 Dapagliflozin 10 mg Metoprolol Succinate 25 mg Tablets Manufactured by Exemed Pharmaceuticals India in Healthy Adult Male Human Subjects under Fasting Condition
Eris Lifesciences Limited1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
This is a randomized, open-label, two-treatment, two-period, single-dose crossover bioequivalence study to compare Dapagliflozin 10 mg + Metoprolol Succinate SR 25 mg tablets manufactured by Eris Lifesciences Ltd. with the reference product Dapaglyn MX 25 under fasting conditions in 36 healthy adult male subjects.
Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf) will be evaluated using validated bioanalytical methods. Bioequivalence will be conducted if 90% confidence intervals for test/reference ratios fall within 80.00%-125.00%. safety will be monitored through clinical assessments, laboratory tests, and adverse event reporting in compliance with CDSCO and ICP-GCP guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy male human subjects, age in the range of
- •45 years both inclusive.
- •Body Mass Index between 18.5-30.0 Kg/m2 extremes included with minimum of 48 kg weight.
- •Subjects with normal findings as determined by baseline history, physical examination and vital sign examination.
- •Subjects with clinically acceptable findings as determined by haemogram, biochemistry including creatinine clearance, urinalysis, 12 lead ECG and chest X-ray (if done).
- •Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in each study period and adherence to all study restrictions.
- •No history of significant alcoholism.
- •No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
- •Non-smokers as evident from the history obtained.
- •Willing to provide written informed consent to participate in the study.
排除标准
- •Known history of hypersensitivity to Dapagliflozin and Metoprolol Succinate or related drugs or any of the excipients.
- •Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- •Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP.
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- •History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- •Not eligible as per OVIS.
- •Volunteer who have donated blood or loss of blood up to 150 ml within 30 days or in between 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study medication.
- •History of malignancy or other serious diseases.
- •Subjects with positive result of HIV tests or HBsAg or Hepatitis-C tests during screening.
- •Found positive in breath alcohol test and/or urine test for drug abuse.
- •History of problem in swallowing of tablet/capsule.
- •Any contraindication to blood sampling.
- •Male human subjects not willing to use birth control measures, from the period-I dosing until the completion of the study.
- •Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
- •Use of hormonal contraceptives either oral or implants.
研究者
Dr Nirav Panchal
Sycon Clinical Research Pvt Ltd.
研究点 (1)
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