Evaluation of felodipine as a potential perpetrator of pharmacokinetic drug-drug interactions

Eur J Clin Pharmacol. 2014 Sep;70(9):1115-22. doi: 10.1007/s00228-014-1716-8. Epub 2014 Jul 17.

Abstract

Objective: To evaluate felodipine as a potential perpetrator of pharmacokinetic drug-drug interactions (PK-DDIs) involving cytochrome P450 (CYP) enzymes and P-glycoprotein (P-gp).

Methods: Felodipine extended-release 10 mg was administered daily to six healthy subjects for 7 days (days 1-7). Subjects were administered a modified Inje cocktail comprising the selective probe substrates caffeine 100 mg (CYP1A2), losartan 25 mg (CYP2C9), omeprazole 20 mg (CYP2C19), dextromethorphan 30 mg (CYP2D6), midazolam 2 mg (CYP3A) and digoxin 250 μg (P-gp) on day 0 (prior to felodipine exposure) and day 7 (after felodipine exposure). Plasma samples were collected over 24 h and drug concentrations measured by UPLC-MS/MS.

Results: The geometric means of the area under the plasma concentration-time curve ratios (probe AUC after felodipine exposure/probe AUC prior to felodipine exposure) and 95% confidence intervals for each probe were: caffeine 0.91 (0.64-1.30), losartan 1.05 (0.95-1.15), omeprazole 1.17 (0.78-1.76), dextromethorphan 1.46 (1.00-2.12), midazolam 1.23 (0.99-1.52) and digoxin 1.01 (0.89-1.15).

Conclusion: Felodipine may be a weak in vivo inhibitor of CYP3A and CYP2D6 but is unlikely to act as a significant perpetrator of PK-DDIs.

Publication types

  • Clinical Trial

MeSH terms

  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / metabolism
  • Adult
  • Antihypertensive Agents / pharmacology*
  • Caffeine / blood
  • Caffeine / pharmacokinetics
  • Calcium Channel Blockers / pharmacology*
  • Cytochrome P-450 Enzyme Inhibitors / pharmacology*
  • Cytochrome P-450 Enzyme System / genetics
  • Cytochrome P-450 Enzyme System / metabolism
  • Dextromethorphan / blood
  • Dextromethorphan / pharmacokinetics
  • Digoxin / blood
  • Digoxin / pharmacokinetics
  • Drug Interactions
  • Felodipine / pharmacology*
  • Female
  • Genotype
  • Humans
  • Losartan / blood
  • Losartan / pharmacokinetics
  • Male
  • Midazolam / blood
  • Midazolam / pharmacokinetics
  • Omeprazole / blood
  • Omeprazole / pharmacokinetics
  • Young Adult

Substances

  • ATP Binding Cassette Transporter, Subfamily B, Member 1
  • Antihypertensive Agents
  • Calcium Channel Blockers
  • Cytochrome P-450 Enzyme Inhibitors
  • Caffeine
  • Dextromethorphan
  • Digoxin
  • Cytochrome P-450 Enzyme System
  • Losartan
  • Omeprazole
  • Felodipine
  • Midazolam

Associated data

  • ANZCTR/ACTRN12611000811909