Impact of Bariatric Surgery on Pharmacokinetic Study of Simvastatin and Carvedilol
Summary
Obesity affects more than 1 in 3 adults in the U.S. It is commonly associated with reduced quality of life and complications such as metabolic syndrome, heart disease, high blood pressure and sleep disorders. The gastric bypass, also known as Roux-en-Y gastric bypass (RYGB), is one of the most common weight-loss surgeries due to the reliable and long-lasting weight loss and the effective remission of obesity-associated conditions. Although the impact of obesity on absorption, distribution, metabolism and excretion has been documented for several drugs, label recommendations might not account for specific population subgroups, specially morbidly obese patients and obese patients post-bariatric surgery. This study aims to investigate the impact of obesity and RYGB surgery on the kinetic disposition of simvastatin (Study A) and carvedilol (Study B).
Timeline
- Start
- 2019-06-01
- Primary completion
- 2022-08
- Completion
- 2023-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carvedilol | Other / unclassified | 25 mg | Oral |
| Comparator | Metoprolol | Other / unclassified | 100 mg | Oral |
| Comparator | Midazolam | Small molecule | 2 mg | Intravenous |
| Comparator | Simvastatin | Small molecule | 40 mg | Oral |