Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-02 @ 4:12 AM
Study NCT ID:
NCT03378960
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity
Sponsor:
Emilio Vargas Castrillón
Organization:
Study Overview
Official Title:
Bioavailability Study of Omeprazole (20 mg) at Steady State (Multiple Dose) in Patients Who Have Undergone Bariatric Surgery
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBS-2011/001
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: