Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
Condition: Esophagitis; Gastroesophageal Reflux; Stomach Ulcer; Duodenal Ulcer
MeSH terms: Gastroesophageal Reflux; Esophagitis; Duodenal Ulcer; Stomach Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a
      class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially
      available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers,
      erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study
      evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid
      suppression is considered to be correlated with clinical efficacy.

      In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each
      volunteer. First, one of the dosages will be orally administered for five days. Then, a nine
      to sixteen day period without study drug administration will follow prior to the
      administration of the next dosage, for again five days. Each volunteer will have a total of
      four study drug administration periods.

      After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be
      done for four days. After the last study drug intake in period 4 pharmacokinetic blood
      sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood
      draws over a pre-determined time period. The pharmacokinetic blood sampling measures the
      medication concentration in the blood at pre-defined time points.

      After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured
      for 24 hours by means of a thin tube that will be inserted into the stomach through the
      nostril to evaluate the efficacy of the different dosages of STU-Na.
    

Detailed description: 
      S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a
      class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially
      available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers,
      erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study
      evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid
      suppression is considered to be correlated with clinical efficacy.

      In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each
      volunteer. First, one of the dosages will be orally administered for five days. Then, a nine
      to sixteen day period without study drug administration will follow prior to the
      administration of the next dosage, for again five days. Each volunteer will have a total of
      four study drug administration periods.

      After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be
      done for four days. After the last study drug intake in period 4 pharmacokinetic blood
      sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood
      draws over a pre-determined time period. The pharmacokinetic blood sampling measures the
      medication concentration in the blood at pre-defined time points.

      After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured
      for 24 hours by means of a thin tube that will be inserted into the stomach through the
      nostril to evaluate the efficacy of the different dosages of STU-Na.
    

Intervention name(s): S-Tenatoprazole-Na (STU-Na)
Intervention type(s): Drug
Intervention description(s): 30 mg, 60 mg, 90 mg and 120 mg of STU-Na for 5 days every morning
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: S-Tenatoprazole-Na; Pharmacokinetic; intragastric pH recording; dose-response