The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability of omeprazole 20 mg at one month and six months after surgery. Other objectives were: * To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass surgery and patients who avoid it. * To asses other pharmacokinetic parameters, demographic parameters and drug safety. Study design It was planned a mixed design which intended to compare the bioavailability in patients with gastric bypass (before and after surgery) and control subjects matched by sex and body mass index (BMI) post-surgery. This was a single-dose, open-label, crossover bioavailability study of omeprazole in surgical group and controls.
Study Type
INTERVENTIONAL
Purpose
OTHER
Masking
NONE
Enrollment
43
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, Spain
AUC variation Pharmacokinetic parameters
Omeprazole Biodisponibility
Time frame: Baseline and 6 month after bariatric surgery
Tmax variation
Time required to reach the maximum concentration of Omeprazole in blood after its administration.
Time frame: Baseline and 6 month after bariatric surgery
Cmax variation
Maximum concentration of Omeprazole in blood after its administration.
Time frame: Baseline and 6 month after bariatric surgery
AUC 1 month
Omeprazole Biodisponibility
Time frame: 1 month after surgery
Tmax 1 month
Time required to reach the maximum concentration of Omeprazole in blood after its administration
Time frame: 1 month after surgery
Cmax 1 month
Maximum concentration of Omeprazole in blood after its administration.
Time frame: 1 month after surgery
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