Health Condition 1: null- Pulmonary Tuberculosis
Conditions
Interventions
Intervention1: Tablet Verapamil (IR): Stage I: Day 1 to Day 5: Subjects will be asked to attend NITRD clinic every morning for 5 days, preferably empty stomach or at least one hour prior to meals. The
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: All the following criteria must be met at screening and prior to enrolment: 1.Pulmonary TB patients in their sixth month of RNTCP Category I anti-TB treatment who were new sputum smear positive cases at the time of treatment initiation and should have achieved sputum smear negativity during treatment. 2.Willing/ consenting male and female patients between the age group of 18 to 55 years (both inclusive) and weighing 45-75 kgs (both inclusive) 3.Able to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study 4.Patients should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray
Exclusion criteria
Exclusion criteria: Any of the following criteria will preclude the patient from being enrolled in the study: 1.Symptoms suggestive of congestive heart failure (i.e. edema, orthopnea, paroxysmal nocturnal dyspnea) 2.Current use of any other medications except those taking INH, rifampicin, and pyridoxine 3.Comorbidities: HIV, cardiac arrhythmia, diabetes mellitus, other uncontrolled medical condition, active substance abuse 4.Laboratory abnormalities: Hemoglobin 2.5 times upper limit of normal 5.Physical examination findings: Systolic blood pressure (SBP) 6.Diagnostic testing abnormalities: conduction delay on ECG (PR >200ms or QRS >120ms), ejection fraction 7.Pregnant females as determined by positive serum or urine hCG test at Screening or prior to the first dose of study drug (Day 1) 8.Lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY ENDPOINT 1.Area under the plasma concentration â?? time curve over the steady state dosing interval. 2.Cmax-ss: Maximum concentration over the steady state dosing interval. 3.Cmin-ss: Minimum concentration over the steady state dosing interval Timepoint: Stage I - At Day 7 and Day 22 Stage II - At Day 9 1.Css-avg: Average concentration over the steady state dosing interval. 2.Percentage fluctuation: 3.Tmax: 4.Safety and tolerability as assessed by reported adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Css-avg: Average concentration over the steady state dosing interval. 2.Percentage fluctuation: 3.Tmax: Time of maximum measured plasma concentration over the steady state dosing interval. 4.Safety and tolerability as assessed by reported adverse events Timepoint: Stage I - Day 7 and Day 22 Stage II - Day 9 | — |
Countries
India
Contacts
Public ContactDr C Padmapriyadarsini
National Institute for Research in Tuberculosis
Outcome results
None listed