An Open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet of The ACME Laboratories Ltd., with VASTAREL® (Trimetazidine) MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare bioequivalence of WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet of The ACME Laboratories Ltd., with VASTAREL® (Trimetazidine) MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adult human subjects under fasting conditions.
研究概览
简要总结
An Open label,balanced, randomized, two-treatment, two-period, two-sequence, single oral dose,crossover, bioequivalence study of WHILST (Trimetazidine Hydrochloride) 35 mgModified Release Tablet of The ACME Laboratories Ltd., with VASTAREL® (Trimetazidine)MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE inhealthy adult human subjects under fasting conditions.
Primaryobjective:
To compare bioequivalenceof WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet of TheACME Laboratories Ltd., with VASTAREL® (Trimetazidine) MR 35 mgModified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adulthuman subjects under fasting conditions.
Secondaryobjective:
To monitor and assesssafety and tolerability of the investigational products in healthy adult, humansubjects under fasting condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy human subjects aged from 18 to 55 years, both ages inclusive.
- •2.BMI range from 18 to 30 kg/m2 inclusive with the body weight ≥ 45 kgs.
- •3.Normal vital signs [blood pressure (Systolic 90-140 mmHg, Diastolic 60-90mmHg), pulse rate 60-100 beats/min), respiratory rate (15-20 breaths/min) and body temperature (96.0-99.8oF)].
- •4.Normal medical and surgical history as evaluated by the physician or principal investigator prior to start of the study.
- •5.Normal 12-lead electrocardiogram (ECG) & chest X-Ray (P/A view).
排除标准
- •1.Contraindications or Hypersensitivity to Trimetazidine or to any of the components of the formulation or excipients.
- •2.History of Acute or chronic metabolic acidosis, Severe ketosis, diabetic coma or history of diabetic coma, type 1 diabetic patients 3.History of severe infection, surgery, severe trauma (blood sugar control should preferably be done by insulin).
- •4.History of Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia 5.History or presence of any disease (Gastric, renal, respiratory, cardiac, neurological etc.) according to the opinion of the physician.
- •6.History or presence of significant alcoholism or drug abuse in the past one year.
- •7.History or presence of significant smoking (more than 09 cigarettes or bidis/day) or consumption of tobacco products (pan, gutkha) and refusal to restrain from smoking for 48.00 hours before first period check-in until last sample collection.
- •8.History or presence of significant asthma, urticaria or other allergic reactions.
- •10.Difficulty in swallowing oral dosage forms.
结局指标
主要结局
To compare bioequivalence of WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet of The ACME Laboratories Ltd., with VASTAREL® (Trimetazidine) MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adult human subjects under fasting conditions.
时间窗: From day 1 to Day 10
次要结局
- To monitor and assess safety and tolerability of the investigational products in healthy adult, human subjects under fasting condition(From day 1 to Day 10)