Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.
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Current treatment for gastroesophageal reflux disease(GERD)confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric acid suppression. Clinical data on lavoltidine demonstrates a rapid onset of action, high potency, and prolonged duration of effect after single dose. Since tolerance to the class of compounds to which lavoltidine belongs may be dose dependent, the current study is designed to determine if 40mg lavoltdine given for 7days develops tolerance.
To determine the degree of pharmacodynamic tolerance following seven days administration of lavoltidine 40mg on gastric pH as assessed by percentage of 24hrs pH>4. [ Time Frame: seven days ]
Secondary Outcome Measures :
To determine whether or not significant pharmacodynamic tolerance occurs as early as the second dose of 40mg lavoltidine. Safety and tolerance of seven days administration of lavoltidine 40 mg, in healthy male volunteers. [ Time Frame: seven days ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male, from 18-55 years
Have BMI from 19-30 kg/m2
do not present with abnormal clinical lab findings