Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol.

• Status: Completed
• Trial end date: 2017-03-10
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to investigate whether intravenous lipid emulsion is effective in attenuating the clinical effects of a cardioactive drug, exemplified by the beta-blocking agent metoprolol. In addition, the investigators will clarify how intravenous lipid emulsion affects the pharmacokinetic parameters of metoprolol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mikkel Bring Christensen
• Treatments: Fat Emulsions, Intravenous; Metoprolol; Pharmaceutical Solutions; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• healthy male.

Exclusion Criteria:

• Abnormal blood levels of sodium, potassium, creatinine, alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, albumin, bilirubin, hemoglobin, HbA1c, cholesterol fractions.

• Abnormal urine albumin to creatinine ratio.

• Abnormal function of CYP2D6 metabolism (ultrarapid or slow metabolizer)

• Any heart disease or hypertension

• Sinoatrial block

• Second or third degree atrioventricular block

• Heart failure

• profound bradycardia or hypotension

• sinoatrial node disease

• metabolic acidosis

• untreated pheochromocytoma

• asthma

• chronic obstructive pulmonary disease

• intermittent claudicatio

• diabetes

• Allergy to egg, soy or peanut protein and allergy to any active or inactive ingredients contained in metoprolol (Seloken) or the lipid emulsion (Intralipid)

• Raynaud's syndrome

• Prinzmetal's angina