A comparison of the pharmacokinetics, clinical efficacy, and tolerability of once-daily tramadol tablets with normal release tramadol capsules.

Abstract:

:This report describes a pharmacokinetic study and a clinical study of three different formulations of oral tramadol: once-daily tramadol tablets 150 and 200 mg, and normal release tramadol capsules 50 mg 8-hourly. The randomized, open-label, crossover pharmacokinetic study included 22 subjects. The three treatments showed equivalent mean systemic availability of tramadol. The mean relative systemic availabilities (90% confidence intervals) for the once-daily tablets 150 mg and the once-daily tablets 200 mg versus the normal release capsules were 89.6 (83.3-95.8)% and 90.5 (84.6-96.8)%, respectively. The values for the once-daily tablet 150 mg versus the once-daily tablet 200 mg were 99.0 (92.6-105.9)%. The randomized, double-blind, double-dummy, crossover clinical study included 134 patients with moderate osteoarthritic pain. The three treatments showed similar efficacy; they all reduced patients' pain scores from baseline and there were no significant treatment differences in pain scores during treatment. The three treatments were also well tolerated.

journal_name

J Pain Symptom Manage

authors

Bodalia B,McDonald CJ,Smith KJ,O'Brien C,Cousens L

doi

10.1016/s0885-3924(02)00642-5

subject

Has Abstract

pub_date

2003-02-01 00:00:00

pages

142-9

issue

2

eissn

0885-3924

issn

1873-6513

pii

S0885392402006425

journal_volume

25

pub_type

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