J Clin Pharmacol
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DRUG INTERACTIONS

Lack of Pharmacokinetic Interaction Between Omeprazole or Lansoprazole and Ivabradine in Healthy Volunteers: An Open-Label, Randomized, Crossover, Pharmacokinetic Interaction Clinical Trial

A. Portolés, MD, PhD, A. Calvo, MD, A. Terleira, MD, PhD, L. Laredo, MD, PhD, G. Resplandy, MD, C. Gorostiaga, MD, PhD and A. Moreno, MD, PhD

From the Clinical Pharmacology Studies Unit, Clinical Pharmacology Service, Hospital Clínico San Carlos, Madrid, Spain (Dr Portolés, Dr Calvo, Dr Terleira, Dr Laredo, Dr Moreno); Laboratorios Servier, Madrid, Spain (Dr Gorostiaga); and Cardiovascular Division, Institut de Recherches Internationales Servier, Courbevoie Cedex, France (Dr Resplandy).

The effects of omeprazole and lansoprazole (CYP3A4 inhibitors) on the pharmacokinetics of a single dose of ivabradine (metabolized via CYP3A4) and its active metabolite (S18982) were assessed. Pharmacodynamics and safety were secondary objectives. An open-label, randomized, crossover, phase I, pharmacokinetic interaction design was used. Volunteers received a single oral dose of ivabradine (10 mg), were randomized to receive either omeprazole (40 mg) or lansoprazole (60 mg) for 5 days, and were administered an ivabradine dose on the sixth day. Crossover was performed after washout. Pharmacokinetic parameters for ivabradine did not vary significantly after omeprazole (Cmax: 45.0 ± 36.6 vs 42.7 ± 27.6 ng/mL, P = .98; AUC: 128 ± 87 vs 126 ± 63 ng/mL, P = .82) or lansoprazole administration (Cmax: 45.0 ± 36.6 vs 41.3 ± 29.4 ng/mL, P = .70; AUC: 128 ± 87 vs 123 ± 50, P = .73). Analyses of S18982 pharmacokinetic parameters showed similar results. Coadministration of either omeprazole or lansoprazole did not significantly affect the pharmacokinetics of a single dose of ivabradine. No pharmacodynamic interaction or safety concerns were evidenced.

Key Words: pharmacokinetics • interaction • ivabradine • omeprazole • lansoprazole • inhibition • healthy volunteers • clinical trial

Address for reprints: Dr A. Portolés, Clinical Pharmacology Studies Unit, Clinical Pharmacology Service, Hospital Clínico San Carlos, c/Prof. Martín Lagos s/n, 28040 Madrid, Spain; e-mail: aportoles.hcsc{at}salud.madrid.org.


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