The Effect of Food on Tramadol and Celecoxib Bioavailability Following Oral Administration of Co-Crystal of Tramadol-Celecoxib (CTC): A Randomised, Open-Label, Single-Dose, Crossover Study in Healthy Volunteers.

Clinical Drug Investigation
Gregorio EncinaSebastián Videla

Abstract

Co-Crystal of Tramadol-Celecoxib (CTC), in development for the treatment of moderate to severe acute pain, is a first-in-class co-crystal containing a 1:1 molecular ratio of two active pharmaceutical ingredients; rac-tramadol·HCl and celecoxib. This randomised, open-label, crossover study compared the bioavailability of both components after CTC administration under fed and fasting conditions. Healthy adults received single doses of 200 mg CTC under both fed and fasting conditions (separated by a 7-day washout). Each dose of CTC was administered orally as two 100 mg tablets, each containing 44 mg tramadol·HCl and 56 mg celecoxib. In the fed condition, a high-fat, high-calorie meal [in line with recommendations by the US Food and Drug Administration (FDA)] was served 30 min before CTC administration. Tramadol, O-desmethyltramadol and celecoxib plasma concentrations were measured pre- and post-dose up to 48 h. Pharmacokinetic parameters were calculated using non-compartmental analysis. Safety was also assessed. Thirty-six subjects (18 female/18 male) received one or both doses of CTC; 33 provided evaluable pharmacokinetic data under fed and fasting conditions. For tramadol and O-desmethyltramadol, fed-to-fasting ratios of geometr...Continue Reading

References

Jan 9, 2010·European Journal of Clinical Investigation·UNKNOWN Italian Medicines Agency (AIFA) Research & Development Working Group
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May 20, 2015·Clinical and Molecular Allergy : CMA·Carlo AgostiniEnrico Maggi
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Feb 18, 2017·The American Journal of Nursing·Rosemary C PolomanoCarla R Jungquist
Sep 10, 2017·British Journal of Clinical Pharmacology·Sebastián VidelaCarlos Plata-Salamán

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Citations

Apr 27, 2019·Expert Opinion on Investigational Drugs·Neus GasconCarlos Plata-Salamán

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