Status:
COMPLETED
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
Lead Sponsor:
STEBA France
Collaborating Sponsors:
STEBA LABORATORIES LTD.
Conditions:
Esophagitis
Gastroesophageal Reflux
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 wi...
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 wi...
Eligibility Criteria
Inclusion
- Healthy male volunteers aged 18 to 55 years inclusive
- Able to understand the nature of the study and to give written informed consent
- Able to communicate well with the investigator himself or his/her representatives
- Able not to smoke during each hospitalization
- Normal physical examination at the screening visit
- Body Mass Index between 18 kg/m² and 35 kg/m² at the screening visit
- Normal blood pressure and heart rate measured under standardized conditions at the screening visit after at least 5 minutes of rest in a supine position: SBP within 90 and 140 mmHg, DBP within 40 and 85 mmHg, and HR within 40 to 85 bpm
- Normal 12-lead electrocardiogram at screening visit recorded after at least 5 minutes of rest: PR within 120 and 200 ms, QRS below or equal to 120 ms, and QTc below or equal to 440 ms
- Laboratory results within the normal ranges or considered not being of clinical relevance by the investigator
Exclusion
- Vegetarians
- Positive to H. pylori by 13C urea breath test or stool antigen test at screening visit
- Contra-indication to proton pump inhibitors treatment
- Previous participation in a trial with PPIs within 3 months
- Current or historical evidence of clinically relevant cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease
- Any other acute or chronic disease which could influence the volunteer's health and/or the study results
- Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or hernia repair
- Receipt of medication (including 'over the counter' preparations) within two weeks of dosing
- Use of enzyme inducers or enzyme inhibitor drugs within the last three months before the first drug administration
- Participation in a clinical trial involving receipt of a licensed (marketed) medicinal product or of an unlicensed (investigational) medicinal product within one month before the study
- Past or current drug exposure amounting to drug abuse or addiction
- Past or current alcohol exposure amounting to alcohol abuse or addiction; (i.e. \> 28 units per week for males, where 1 unit = one measure of spirit (25 mL), one glass of wine (125 mL) or ½ pint beer)
- Currently smoke \>10 cigarettes per day
- Donation of blood or any other major blood loss (\>500 mL) within three months before the study
- Unwilling or unable to comply with the study protocol for any reason or in the opinion of the investigator should not participate in the study
- Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV1 or HIV2 antibody at screening
- Known allergy or intolerance to lactose
- Known allergy or intolerance to any other compound in the study drug or any other closely related compound
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00284908
Start Date
September 1 2006
End Date
November 1 2006
Last Update
March 24 2008
Active Locations (1)
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1
Healthcare Discoveries, Inc.
San Antonio, Texas, United States, 78229