Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Percentage of time over 24 hours during which gastric pH is > 4
研究概览
简要总结
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.
详细描述
There will be 3 groups of treatment; each group will consist of 18 subjects with the treatment regimens :
- Treatment I : 1 caplet of DLBS2411 250 mg and 1 placebo caplet of DLBS2411, once daily
- Treatment II : 2 caplets of DLBS2411 250 mg, once daily
- Treatment III : 2 placebo caplets of DLBS2411, once daily
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment 1
one dose of DLBS2411 @250 mg
干预措施: DLBS2411 (Drug)
Treatment II
two doses of DLBS2411 @250 mg
干预措施: DLBS2411 (Drug)
Treatment III
干预措施: Placebo DLBS2411 (Drug)
结局指标
主要结局
Percentage of time over 24 hours during which gastric pH is > 4
时间窗: 24 hours
Percentage of time over 24 hours during which gastric pH is \> 4 after a single dose of study medication
次要结局
- The onset of action(24 hours)
- 24-hour median gastric pH(24 hours)
- Gastric pH at the end of study(3 days)
- Change of ECG description from baseline(baseline and 3 days after treatment initiation)
- Routine haematology(Baseline and 3 days after treatment initiation)
- Liver function(baseline and 3 days after treatment initiation)
- Renal function(Baseline and 3 days after treatment initiation)
- Urinalysis parameters(Baseline and 3 days after treatment initiation)
- Adverse events(3 days or until all adverse events have been recovered or stabilized (which ever comes first))