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Gastric pH Regulation in Healthy Volu...

Efficacy and Safety of DLBS2411 in Healthy Volunteers

Sponsored by Dexa Medica Group

About this trial

Last updated 12 years ago

Study ID

DLBS2411-0111

Status

Completed

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18 to 45 Years
Male
Male

Trial Timing

Ended 12 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Male subjects with age of 18-45 years

- Healthy as confirmed by vital signs, clinical and laboratory assessments (normal blood pressure, normal plasma glucose level, normal values of all hematological parameters, adequate liver and renal function)

- BMI 18-25 kg/m2

- Able to take oral medication

No

Exclusion Criteria

- Gastric pH ≥ 4 at screening

- Currently being an active smoker and suffering from chronic alcoholism

- History of or currently peptic ulcer

- Having clinical diagnosis of Zollinger Ellison syndrome

- Taking any H2RAs, PPIs, antacids, or gastric mucosal protectors within 2 weeks prior to screening

- Taking any other medicines, supplements, or herbals within 3 days prior to screening

- History of gastro-intestinal disturbances necessitating long-term treatment with any acid suppressing medication, antacids, or gastric mucosal protectors

- The presence of any chronic diseases

- Currently being afflicted by serious infection(s)

- Participation in any other clinical studies within 30 days prior to screening

Locations

Location

Status