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 VASTARELÂ® (Trimetazidine) MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adult human subjects under fasting conditions.

The ACME Laboratories Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年4月3日

试验速览

暂无简介。

•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).

•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.
•9.History of difficulty in donating blood or difficulty in accessibility of veins.
•10.Difficulty in swallowing oral dosage forms.

发起方