None listed
Conditions
Interventions
None listed
Sponsors
Dabur Research Development Centre Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Clinically normal physical findings at the time of screening visit 3. Laboratory values (CBC, CT, BT, Liver profile) within the normal range 4. Negative Urine pregnancy test at the time of screening for female participants 5. Ready to sign informed consent form and follow study procedure
Exclusion criteria
Exclusion criteria: 1. Immunocompromised subjects or those suffering from any serious or debilitating medical condition; 2. Subjects with current drug, tobacco or alcohol abuse; 3. Subjects with diabetes/hypertension; 4. Subjects with presence of any disease/condition or physical defect which could preclude subjects from complying with study procedures. 5. Subjects receiving treatment with any medication which could alter or influence stomach acidity or study drug/placebo activity; 6. Subjects who investigator feels may be unreliable or unsuitable to participate in a clinical trial 7. Subject having participated in a clinical trial in the previous 30 days 8. Pregnant and Lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time required for study products to induce statistically significant acid neutralization effect after a single dose administration.Timepoint: Baseline, End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time needed for subjects to demonstrate a one pH unit change after a single dose administration 2. Time needed to achieve a pH of 3.5 or greater after a single dose administration 3. Safety evaluation through assessment of AE & concomitant medications during the study Timepoint: Baseline, End of Study | — |
Countries
India
Contacts
Public ContactDr Sasibhushan Vedula
Target Institute of Medical Research Pvt. Limited (TIMER)
Outcome results
None listed