Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566794
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
KF20224-trial Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
KF20224-tutkimusBeetasalpaajan ja tulehduskipulääkkeen Vaikutus CYP-entsyymivälitteiseen lääkeainemetaboliaan
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KF20224
Brief Summary:
Carvedilol is a non-selective beta-blocker in common clinical use used to treat hypertension heart failure and angina pectoris symptoms associated with coronary artery disease Diclofenac is a non-selective anti-inflammatory drug in general use which is used to treat rheumatic diseases osteoarthritis musculoskeletal pain conditions menstrual pains and migraines among others In our recent experiments involving liver cell enzymes both carvedilol and diclofenac were found to inhibit several cytochrome P450 CYP enzymes central to drug metabolism potentially leading to adverse drug interactions with other drugs metabolized by the same enzyme The purpose of this study is to investigate the effects of the use of carvedilol and diclofenac on the activity of key CYP enzymes in drug metabolism in healthy volunteers using a low-dose model drug combination covering seven CYP enzymes
In an open three-phase randomized crossover study with 12 healthy volunteers the subjects will receive a drug combination of caffeine bupropion repaglinide flurbiprofen omeprazole dextromethorphan midazolam and simvastatin and as a premedication either placebo carvedilol or diclofenac Blood samples will be collected and carvedilol diclofenac caffeine bupropion repaglinide flurbiprofen omeprazole dextromethorphan midazolam and simvastatin pharmacokinetics will be monitored up to 23 hours post dose
In an open three-phase randomized crossover study with 12 healthy volunteers the subjects will receive a drug combination of caffeine bupropion repaglinide flurbiprofen omeprazole dextromethorphan midazolam and simvastatin and as a premedication either placebo carvedilol or diclofenac Blood samples will be collected and carvedilol diclofenac caffeine bupropion repaglinide flurbiprofen omeprazole dextromethorphan midazolam and simvastatin pharmacokinetics will be monitored up to 23 hours post dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None