Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, 28040, Spain
NCT Number: NCT03378960
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 4
Madrid, 28040, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 6 month after bariatric surgery
Omeprazole Biodisponibility
Time frame: Baseline and 6 month after bariatric surgery
Time required to reach the maximum concentration of Omeprazole in blood after its administration.
Time frame: Baseline and 6 month after bariatric surgery
Maximum concentration of Omeprazole in blood after its administration.
Time frame: 1 month after surgery
Omeprazole Biodisponibility
Time frame: 1 month after surgery
Time required to reach the maximum concentration of Omeprazole in blood after its administration
Time frame: 1 month after surgery
Maximum concentration of Omeprazole in blood after its administration.
Emilio Vargas Castrillón
Other
Bioavailability Study of Omeprazole (20 mg) at Steady State (Multiple Dose) in Patients Who Have Undergone Bariatric Surgery
Acronym: OBS-2011/001
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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