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This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as well as its safety in healthy volunteers.
DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is hypothetically more potential than PPIs in suppressing gastric acid as our previous preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+ ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.
There will be 3 groups of treatment; each group will consist of 18 subjects with the treatment regimens :
Clinical examination to evaluate the investigational drug's efficacy will be performed by a 24-hour-gastric pH monitoring after the first dose of study drug administration. Besides, the pH of the gastric fluid will also be measured at the end of study (Day 3 of treatment). Safety examination will be performed at baseline and at end of study. The occurrence of adverse event will be observed during the study.
All subjects will be under direct supervision of a medical doctor during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | one dose of DLBS2411 @250 mg |
|
| Treatment II | Experimental | two doses of DLBS2411 @250 mg |
|
| Treatment III | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS2411 | Drug | 1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time over 24 hours during which gastric pH is > 4 | Percentage of time over 24 hours during which gastric pH is > 4 after a single dose of study medication | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The onset of action | The onset of action, which is defined as time taken to achieve gastric pH of > 4 after the initial dose of study medication | 24 hours |
| 24-hour median gastric pH | 24-hour median gastric pH after the initial dose of study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murdani Abdullah, Dr., dr., SpPD-KGEH | Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital | Jakarta Center | Jakarta Special Capital Region | 10430 | Indonesia |
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| DLBS2411 |
| Drug |
2 caplets of DLBS2411 @250 mg, once daily |
|
| Placebo DLBS2411 | Drug | 2 placebo caplets of DLBS2411, once daily |
|
| 24 hours |
| Gastric pH at the end of study | Gastric pH after a repeated (3-day) dosing of study medication | 3 days |
| Change of ECG description from baseline | ECG will be evaluated at baseline (Day 1st)and at end of study (Day 3rd) | baseline and 3 days after treatment initiation |
| Routine haematology | Routine haematology (hemoglobin level, hematocrit, erythrocyte count, leucocyte count, differentiation of WBC and platelet count) will be evaluated at baseline and at end of study (Day 3rd) | Baseline and 3 days after treatment initiation |
| Liver function | Liver function (ALT, AST, γ-GT, and total bilirubin levels) will be evaluated at baseline and at end of study (Day 3rd) | baseline and 3 days after treatment initiation |
| Renal function | Renal function (serum creatinine level) will be evaluated at baseline and at end of study (Day 3rd) | Baseline and 3 days after treatment initiation |
| Urinalysis parameters | Urinalysis parameters (urine color, pH, presence of glucose, protein, sediments, epithelial cells, erythrocyte, leucocyte, and others) will be evaluated at baseline and at end of study (Day 3rd) | Baseline and 3 days after treatment initiation |
| Adverse events | Type and number of adverse events as well as number of subjects experiencing the events will be observed and evaluated during study period (3 days of treatment)and until the end of study or all adverse events have been recovered or stabilized (which ever comes first). | 3 days or until all adverse events have been recovered or stabilized (which ever comes first) |