EUCTR2013-002260-10-NL进行中（未招募）不适用
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. - Effect of RYGB on the absorption of metoprolol immediate release.
Medisch Centrum Leeuwarden0 个研究点开始时间: 2013年6月6日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •Exclusion criteria
- •- Pregnancy
- •- Alcohol: more than 7 drinks a week or 4 or more drinks during a single occasion
- •- 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
- •- Use of a proton pump inhibitor
- •- Use of laxatives
- •- An existing contraindication for the use of metoprolol
- •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
研究者
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