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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/08/007157
Enrollment
24
Registered
2016-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: CDRI08 Bacosides Enriched Standardized Extract of Bacopa (BESEB): CDRI08 Bacosides Enriched Standardized Extract of Bacopa (BESEB) twice daily for fourteen days Control Intervention1: M

Sponsors

CSIR Central Drug Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Known cases of type 2 diabetes mellitus with an HbA1 c of 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

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

MeasureTime frame
Peak plasma concentrations(Cmax) Area under plasma concentration-time curve up to t hr (AUC 0-t) Timepoint: Peak plasma concentrations(Cmax) Area under plasma concentration-time curve up to t hr (AUC 0-t)—

Secondary

MeasureTime frame
Safety of combination therapyTimepoint: every week for four weeks—

Countries

India

Contacts

Public ContactDr Shobhana Vaish

King George Medical University

satyendra.sonkar@gmail.com05222257540

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026