CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Antonius Hospital
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• BMI>40

• undergoing bariatric surgery

Exclusion Criteria:

• use of drug inducing or inhibiting CYP3A4 activity

• pregnancy, breastfeeding

• renl insufficiency