The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.
Eligible H. pylori negative, normal gastric acid secreting, healthy volunteers will be treated by the study medications in a randomized, open-label, cross-over study.Up to 60 volunteers may be enrolled to ensure that at least 30 subjects will complete all the study treatments. Omeprazole 20 mg will be administered before breakfast. Vecam 40/300 and Vecam 20/300 will be administered at bedtime w/o food. 24-hour gastric pH will be measured after the fifth dose (day 5).Following screening procedures, subjects will be randomly assigned to receive the different treatments. All pH measurements will be done in the study center under supervised conditions. All drug administrations will be supervised. This study is part of the Vecam clinical development plan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
20 mg capsule, orally, once daily (before breakfast) for 5 days.
1 capsule, orally, once daily at bedtime for 5 days.
1 capsule, orally, once daily at bedtime for 5 days.
Clinical Applications Laboratories Inc.
San Diego, California, United States
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Time frame: 5 days
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Time frame: 5 days
To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Time frame: 5 days
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.
Time frame: 5 days
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose
Time frame: 5 days
To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.
Time frame: 5 days
To asses Vecam 40/300 administered at bedtime w/o food vs. Omeprazole 20 mg administered before breakfast calculated as percent time pH ≥4 during 24-hour interval and nocturnal hours at early dosing days.
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Time frame: 5 days
To assess the safety of Vecam 40/300 and Vecam 20/300 administered at bedtime vs. Omeprazole 20 mg administered before breakfast during treatment period.
Time frame: 5 days