Single‐dose pharmacokinetics of co‐crystal of tramadol–celecoxib: Results of a four‐way randomized open‐label phase I clinical trial in healthy subjects

• Published in: British journal of clinical pharmacology Vol. 83; no. 12; pp. 2718 - 2728
• Main Authors: Videla, Sebastián, Lahjou, Mounia, Vaqué, Anna, Sust, Mariano, Encabo, Mercedes, Soler, Lluis, Sans, Artur, Sicard, Eric, Gascón, Neus, Encina, Gregorio, Plata‐Salamán, Carlos
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.12.2017
• Subjects: Administration, Oral; Adolescent; Adult; Analgesics, Opioid - administration & dosage; Analgesics, Opioid - blood; Analgesics, Opioid - chemistry; Analgesics, Opioid - pharmacokinetics; Area Under Curve; celecoxib; Celecoxib - administration & dosage; Celecoxib - chemistry; Celecoxib - pharmacokinetics; co‐crystal; Cross-Over Studies; Crystallization; Cyclooxygenase 2 Inhibitors - administration & dosage; Cyclooxygenase 2 Inhibitors - blood; Cyclooxygenase 2 Inhibitors - chemistry; Cyclooxygenase 2 Inhibitors - pharmacokinetics; Drug Administration Schedule; Drug Combinations; Drug Compounding; Female; Half-Life; Healthy Volunteers; Humans; Male; Metabolic Clearance Rate; Middle Aged; Models, Biological; pain; Pharmacokinetics; Quebec; tramadol; Tramadol - administration & dosage; Tramadol - chemistry; Tramadol - pharmacokinetics; Young Adult; pharmacokinetics; tramadol; pain; celecoxib; co-crystal
• ISSN: 0306-5251; 1365-2125; 1365-2125
• DOI: 10.1111/bcp.13395

Aims Co‐crystal of tramadol–celecoxib (CTC) is a novel co‐crystal molecule containing two active pharmaceutical ingredients under development by Esteve (E‐58425) and Mundipharma Research (MR308). This Phase I study compared single‐dose pharmacokinetics (PK) of CTC with those of the individual refere...