Roux- en Y gastric bypass metoprolol controlled release tablet absorption gastric bypass metoprol tablet met gereguleerde afgifte absorptie
Conditions
Interventions
A single dose, fasting, explorative pharmacokinetic study before and after surgery, with the patient as his own control.
This study concerns an explorative two-phase single oral dose pharmacokinetic
Sponsors
Medisch Centrum Leeuwarden
Leeuwarden
Eligibility
Inclusion criteria
Inclusion criteria: - Female gender; - Age 18-50 years; - Scheduled for Roux-en-Y gastric bypass surgery; - Good liver and kidney function; - Normal ECG; - Intermediate or extensive CYP 2D6 metabolizer, evidenced by genotyping.
Exclusion criteria
Exclusion criteria: - Pregnancy; - Smoking; - Alcohol: more than 7 drinks a week or 4 or more drinks during a single occasion (12); - Use of alcohol during the period 24 hours before until 48 hours after the start of each phase of the study; - Use of metoprolol; - The use of CYP 2D6 inhibiting, inducing or metabolising drugs; - The use of drugs that may interact with metoprolol; o Calcium antagonist; o Lidocaine; o Digoxin; - An existing contraindication for the use of metoprolol (8); o Sick-sinus syndrome; o Second and third degree heart block; o Systolic blood pressure less than 100 mmHg; o Cardiogenic shock; o Sinus bradycardia; o Cardiac failure, overt; o Cardiac failure, moderate to severe; o Untreated pheochromocytoma; o Heart rate less than 45 beats/minute; o First degree heart block (P-R interval 0.24 sec or greater); o Severe bronchial asthma or a history of severe bronchospasm; o Hypersensitivity to metoprolol, related derivatives, other beta-blockers, or any component of the product; o Severe peripheral arterial circulatory disorders; - Previous surgery of the upper gastrointestinal tract; - Disease or any other condition that may interfere with gastrointestinal absorption; - Suffering from dumping syndrome after RYGB surgery;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters that will be determined before and after surgery are Cmax, Tmax and AUC0-24 of metoprolol and its main active metabolite α-OH metoprolol. The main endpoint is the ratio of AUCafter/AUCbefore of metoprolol and α-OH metoprolol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is the quotient of the ratios of the AUC of metoprolol and its metabolite after and before. Other study parameters Blood pressure and heart rate measured at t = 0, 2, 4, 8 and 10 hours after intake of metoprolol. Further analysis After completion of the other pharmacokinetic study with metoprolol immediate release tablet relevant parameters may be compared for further analysis. | — |
Contacts
Public ContactJ.P. Yska
Medisch Centrum Leeuwarden Henri Dunantweg 2
Outcome results
None listed