A study on the effect of gastric bypass on the absortpion of metoprolol immediate release tablet.
- Conditions
- Roux- en-Y gastric bypass<br />Metoprolol<br />immediate release tabletabsorptiongastric bypassmetoprololdirecte afgifte tabletabsorptie
- Registration Number
- NL-OMON29306
- Lead Sponsor
- Medisch Centrum Leeuwarden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Female gender;
- Age 18-50 years;
Exclusion Criteria
- Pregnancy;
- Smoking;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameters that will be determined before and after surgery are Cmax, Tmax, and<br>AUC0-10 of metoprolol and its main active metabolite α-OH metoprolol.<br><br>The main endpoint is the ratio of AUCafter/AUCbefore of metoprolol and α-OH metoprolol.
- Secondary Outcome Measures
Name Time Method Secondary endpoint is the quotient of the ratios of the AUC of metoprolol and its metabolite after and before.<br><br><br>Other study parameters<br>Blood pressure and heart rate measured at t = 0, 2, 4, 8 and 10 hours after intake of metoprolol.<br><br>Further analysis<br>After completion of the other pharmacokinetic study with metoprolol controlled release tablet relevant parameters may be compared for further analysis.