A study on the effect of gastric bypass on the absortpion of metoprolol immediate release tablet.

The effect of Roux-en-Y gastric bypass on the rate and extent of absorption of metoprolol from an immediate release tablet in female bariatric patient volunteers: a single oral dose study before and after surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29306

Enrollment

Registered

2013-05-19

Start date

2013-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Roux- en-Y gastric bypass

Interventions

One month before and six months after Roux-en-Y gastric bypass the patient takes a single oral dose of 100 mg of metoprolol IR tablet A single dose, fasting, explorative pharmacokinetic study before

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 AUC0-10 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 controlled release tablet relevant parameters may be compared for further analysis.	—

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 controlled release tablet relevant parameters may be compared for further analysis.

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Contacts

Public ContactJ.P. Yska

Medisch Centrum Leeuwarden Henri Dunantweg 2

j.p.yska@znb.nl+31 (0)58 2866604

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)