Comparative Bioavailability of a Novel Fixed-dose Combination Etoricoxib and Tramadol.

Autor: Garza-Ocañas L; Pharmacology and Toxicology Department, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico., Badillo-Castaneda CT; Pharmacology and Toxicology Department, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico., Eguía SLM; Pharmacology and Toxicology Department, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico., Zanatta-Calderón MT; Pharmacology and Toxicology Department, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico., Garza JDT; Pharmacology and Toxicology Department, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico., Gómez-Meza MV; Pharmacology and Toxicology Department, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico., Sander-Padilla JG; Research and Development Department, Laboratorios Silanes S.A. de C.V, Mexico City, 11000, Mexico., Lugo-Sánchez LA; Research and Development Department, Laboratorios Silanes S.A. de C.V, Mexico City, 11000, Mexico., Rios-Brito KF; Research and Development Department, Laboratorios Silanes S.A. de C.V, Mexico City, 11000, Mexico., Romero-Antonio Y; Research and Development Department, Laboratorios Silanes S.A. de C.V, Mexico City, 11000, Mexico., González-Canudas J; Research and Development Department, Laboratorios Silanes S.A. de C.V, Mexico City, 11000, Mexico.; Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Mexico City, Mexico.
Jazyk: angličtina
Zdroj: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Nov; Vol. 13 (11), pp. 1253-1259. Date of Electronic Publication: 2024 Jul 31.
DOI: 10.1002/cpdd.1456
Abstrakt: Multimodal analgesia is defined as using several drugs or techniques simultaneously to target different pain pathways or receptors to avoid pain propagation. This study evaluated the pharmacokinetic profile and comparative bioavailability of etoricoxib 90 mg and tramadol 50 mg dosing alone (reference drugs) or in a novel fixed-dose combination (test drug) under fasting conditions in Mexican healthy volunteers. This was a randomized, open-label, 3-way, crossover, single-dose, prospective, and longitudinal study with a 14-day washout period. Eligible subjects were healthy Mexican adult volunteers. The drugs were dosing orally, according to the randomization sequence, after 10 hours of fasting and 4 hours before breakfast with 250 mL of water at room temperature. Serial blood samples were collected before and after dosing, both drugs were quantified using high-performance liquid chromatography coupled with tandem mass spectrometry. Forty-two subjects were enrolled and 38 completed the study (28 men and 14 women, mean age 25.2 years, mean weight 66.6 kg). Test products were considered to have comparative bioavailability if confidence intervals of natural log-transformed for (maximum plasma drug concentration (C max ), (area under the plasma drug concentration-time curve form 0 up to last sampling time (AUC 0-t ), and (area under the plasma drug concentration-time curve from 0 up to infinity (AUC 0-∞ ) data were within the range of 80%-125%. Non-serious adverse events were observed. The results demonstrate that the pharmacokinetic profile and bioavailability of the etoricoxib/tramadol fixed-dose combination are comparable to those of the reference products.
(© 2024 Laboratorios Silanes. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)
Databáze: MEDLINE
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