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Comparative Pharmacokinetics of a Once‐Daily Tramadol Extended‐Release Tablet and an Immediate‐Release Reference Product Following Single‐Dose and Multiple‐Dose Administration
Author(s) -
Karhu David,
Fradette Caroline,
Potgieter Maria Alida,
Ferreira Maria M.,
Terblanché Johann
Publication year - 2010
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270009347673
Subject(s) - tramadol , pharmacokinetics , bioequivalence , medicine , dosing , anesthesia , analgesic , pharmacology , plasma concentration
The pharmacokinetics of a once‐daily formulation of tramadol (Tramadol Contramid OAD 200‐mg tablets) following single‐dose and multiple‐dose administration was compared with that of an immediate‐release product (tramadol IR 50‐mg tablets) in 2 separate studies. In both studies, AUC parameters met bioequivalence criteria, whereas C max of Tramadol Contramid OAD was lower than that of tramadol IR following a 200‐mg daily dosage. After single‐dose administration, the mean tramadol concentration at 1 hour postdose was within the range associated with analgesic efficacy (>100 ng/mL), and the mean concentration remained above this level for the remainder of the dosing interval. Steady state was attained within 48 hours following multiple‐dose administration. Tramadol Contramid OAD provides a rapid rise in plasma concentrations and an equivalent daily systemic exposure as tramadol IR, with a reduction in peak plasma concentrations.