An Open-label, Single-centre, Two period, crossover, Drug Interaction Study to Assess the Effect of Multiple Oral Administration of Bacosides Enriched Standardized Extract of Bacopa (BESEB) (150 mg BD) on the Pharmacokinetics, Safety and Tolerability of antidiabetic drugs Gliclazide 80mg and Metformin 500mg in Indian Patients With Type 2 Diabetes.

CSIR Central Drug Research Institute0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Known cases of type 2 diabetes mellitus with an HbA1 c of <9%.
•2.Age group of 18 to 70 years of either sex. Body weight in the range of 40-80 Kg.
•3.Willing to give written, informed consent prior to inclusion in the study. Willing to comply with protocol requirements, ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study
•4.Type 2 diabetic patients stabilized on Metformin therapy 500mg twice daily or Gliclazide 80mg.
•5.Normal physical & systemic examination
•6.No abnormality detected on ECG
•7.No laboratory evidence of hepatic, renal or cardiac dysfunction

•Are on any form of medication other than study drug.
•smokers or who have consumed tobacco, alcohol, grapefruit juice during a period of 7 days before the study.
•Treatment with certain cardiac medications, history of impaired immunity, drug or alcohol abuse, pulmonary disease, autonomic dysfunction, or psychiatric disorder; or known contraindications to biguanides.
•Have been treated with any known enzyme inducing or inhibiting drugs within 30 days of the study.
•Suffering from any chronic disease which is likely to interfere with the metabolism/evaluation of test drugs.
•History of participation in any clinical trial in last three months and recent loss of 400 ml of blood.

发起方

CSIR Central Drug Research Institute