The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Bio-Kinetic Europe Limited, 14 Great Victoria Street, Belfast BT2 7BA
Belfast, United Kingdom
Bioavailability - Area under Curve of pH at 2 hours
To assess the relative bioavailability of two immediate release formulations of omeprazole/sodium carbonate (Zegerid 20mg capsule and Zegerid 20mg powder for oral suspension)
Time frame: 2 hours
Pharmacodynamics - Area under Curve of pH at 2 hours
To assess the relative pharmacodynamic profiles of two immediate release formulations of omeprazole/sodium bicarbonate (Zegerid® 20mg capsule and Zegerid® 20mg powder for oral suspension).
Time frame: 2 hours
Safety and tolerability of study formulations using measurements of Cmax, tmax and t1/2
To assess the safety and tolerability of these three formulations after single dose oral administration. To include measurements of Cmax, tmax and t1/2
Time frame: pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Bioavailability - measurement of pH over time
To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)
Time frame: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
Bioavailability - measurement of pH over time
To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)
Time frame: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacodynamic Measurements of Cmax, Tmax and t1/2
To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state.
Time frame: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Pharmacodynamic measurements of Cmax, Tmax and t1/2
To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state
Time frame: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose