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Effect of RYGB on the absorption of metoprolol controlled release.

Conditions
Roux- en Y gastric bypassmetoprololcontrolled release tabletabsorptiongastric bypassmetoproltablet met gereguleerde afgifteabsorptie
Registration Number
NL-OMON21648
Lead Sponsor
Medisch Centrum LeeuwardenLeeuwarden
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
NameTimeMethod
Parameters that will be determined before and after surgery are Cmax, Tmax and AUC0-24 of metoprolol and its main active metabolite &#945;-OH metoprolol.<br><br /><br>The main endpoint is the ratio of AUCafter/AUCbefore of metoprolol and &#945;-OH metoprolol.<br />
Secondary Outcome Measures
NameTimeMethod
Secondary endpoint is the quotient of the ratios of the AUC of metoprolol and its metabolite after and before.<br><br><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 /><br /><br>Further analysis<br>After completion of the other pharmacokinetic study with metoprolol immediate release tablet relevant parameters may be compared for further analysis.
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