Effect of Multiple Oral Administration of Bacosides Enriched Standardized Extract of Bacopa (BESEB)(150 mg BD) on the Pharmacokinetics, Safety and Tolerability of Gliclazide 80mg and Metformin 500mg in Indian Patients With Type 2 Diabetes.
- Registration Number
- CTRI/2016/08/007157
- Lead Sponsor
- CSIR Central Drug Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak plasma concentrations(Cmax) <br/ ><br>Area under plasma concentration-time curve up to t hr (AUC 0-t) <br/ ><br>Timepoint: Peak plasma concentrations(Cmax) <br/ ><br>Area under plasma concentration-time curve up to t hr (AUC 0-t) <br/ ><br>
- Secondary Outcome Measures
Name Time Method Safety of combination therapyTimepoint: every week for four weeks