drugset / Trial / NCT03378960

Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity

NCT03378960

SequentialOpen-labelOther

Summary

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.

Timeline

Start
2014-10-31
Primary completion
2015-12-23
Completion
2016-02-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 20 mg

Indications

No indication recorded.