Effect of gastric bypass on the absorption of metoprolol controlled release tablet.

• Conditions: Roux-en-Y gastric bypass; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2013-002274-41-NL
• Lead Sponsor: Medisch Centrum Leeuwaarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-06
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Ten female bariatric surgery patient volunteers will participate in this study.

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Ten female bariatric surgery patient volunteers will participate in this study.

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
- 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
- Use of a proton pump inhibitor
- Use of laxatives
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified