Assessment of Pharmacokinetic Interactions and Therapeutic Effect of Chandraprabha vati with Glimepiride

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Willing to give informed written consent and comply with the study requirements

2 Subject should be able to communicate effectively

3 Non smokers or individuals who smoke less than 5 cigarettes per day

4 Teetotalers or individuals who drink less than 60 ml of high alcohol content liquor or 120 ml of low-alcohol content liquor

5 Body Mass Index between 19 to 25

6 Healthy individuals as evaluated by personal history medical history and general clinical examination

7 BP should be within the range of 100 to 139 systolic and 60 to 89 diastolic Pulse rate should be within the range of 60 to 100 beats per minute Temperature between 97.8 and 99.0 degree Respiratory rate should be within the range of 14 to 18 breaths per minute

8 Normal biochemical hematological and urinary parameters

9 Normal Chest X ray

10 Negative for sexually transmitted diseases Hepatitis B Hepatitis C and Syphilis tests

11 Negative urine test for drugs of abuse for morphine barbiturates benzodiazepines amphetamine cocaine to be performed on the day of check in

12 Negative alcohol breathe analysis to be performed on the day of check in

Exclusion Criteria

1 Subjects incapable of understanding the informed consent

2 History of any major surgical procedure in the past 3 months

3 History of diabetes mellitus tuberculosis and systemic hypertension

4 History suggestive of cardiac gastrointestinal respiratory hepatic renal endocrine neurological metabolic psychiatric or haematological systems judged to be clinically significant

5 History of dysphagia

6 History of any medical disorder that is of significance in the investigators opinion

7 Present or past history of drug abuse

8 History of hypersensitivity to study formulation

9 History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions

10 Present or past history of intake of drugs which potentially modify kinetics or dynamics of study medication or any other medication judged to be clinically significant by the investigator

11 Consumption of grapefruit or its products within 48 hours prior to the start of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 To determine the effect of multiple oral doses of Chandraprabha vati on the single dose Glimepiride administered in healthy adult volunteers <br/ ><br>2 Area under the curve <br/ ><br>3 Total body clearance <br/ ><br>4 Volume of distribution at steady state <br/ ><br>5 Terminal half life <br/ ><br>6 Extent of absolute oral bioavailability <br/ ><br>7 Peak plasma concentration <br/ ><br>8 Time taken to reach Peak plasma concentration <br/ ><br>Timepoint: Baseline <br/ ><br>Third Month <br/ ><br>Sixth Month

Secondary Outcome Measures