NL-OMON38769已完成不适用
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 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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.
排除标准
- •- Pregnancy
- •- 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
研究者
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