Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284908
Status:
COMPLETED
Last Update Posted:
2008-03-24
First Post:
2006-01-31
Brief Title:
Dose-Effect of S-Tenatoprazole-NaSTU-Na 30 mg 60 mg 90 mg and 120 mg in Healthy Volunteers
Sponsor:
STEBA France
Organization:
STEBA France
Study Overview
Official Title:
Pharmacodynamic Dose-Response of S-Tenatoprazole-Na STU-Na 30 mg 60 mg 90 mg and 120 mg in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None