NL-OMON38920CompletedNot Applicable
The effect of Roux-en-Y gastric bypass on the rate and extent of absorption of metoprolol from a controlled release tablet in female bariatric patient volunteers: a single oral dose study before and after surgery - Effect of RYGB on the absorption of metoprolol controlled release.
Medisch Centrum Leeuwarden0 sites10 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •- 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
- •- 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
Investigators
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