논문/저서
| Pharmacokinetic Drug Interaction Between Amlodipine and Tadalafil: An Open-Label, Randomized, Multiple-Dose Crossover Study in Healthy Male Volunteers | ||
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Drug Des Devel Ther. 2022 Feb 19;16:425-433
Pharmacokinetic Drug Interaction Between Amlodipine and Tadalafil: An Open-Label, Randomized, Multiple-Dose Crossover Study in Healthy Male Volunteers
Hyungsub Kim, Shi Hyang Lee, Jina Jung, Sunghee Hong, Hyeong-Seok Lim
Abstract
Subjects and methods: Healthy volunteers (N = 24) were randomly assigned to one of the six sequences that consisted of three treatments: tadalafil (5 mg) alone, amlodipine (10 mg) alone, and tadalafil plus amlodipine. The study drugs were administered orally for 9 d, and the collected serial blood samples were analyzed up to 72 h after the last dosing. Pharmacokinetic parameters were calculated using non-compartmental analysis.
Results: For tadalafil, geometric mean ratios (GMRs) (90% confidence interval (CI)) of the combined therapy over the monotherapy were 1.57 (1.46-1.68) for AUCτ,ss and 1.34 (1.24-1.45) for Cmax,ss. For amlodipine, the GMRs (90% CI) of AUCτ,ss and Cmax,ss were 0.93 (0.90-0.97) and 0.95 (0.91-0.99), respectively. The severity of all observed adverse events (AEs) related to the study drugs was mild, and the frequency of AEs of the combined administration was not significantly different from the monotherapy.
Conclusion: A substantial pharmacokinetic drug interaction between tadalafil and amlodipine was observed with respect to the concentration of tadalafil when administered concomitantly. However, the dose range of the combined administration of tadalafil and amlodipine in the present study was well tolerated by the subjects.
Keywords: amlodipine; drug interaction; pharmacokinetics; tadalafil; tolerability.
PMID: 35221673 PMCID: PMC8865872 DOI: 10.2147/DDDT.S348897
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