A comparison of the pharmacokinetics, clinical efficacy, and tolerability of once-daily tramadol tablets with normal release tramadol capsules.
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.
Bodalia
Bhavesh
B
Gables Medicentre, Coventry, United Kingdom.
McDonald
Chris J
CJ
Smith
Kevin J
KJ
O'Brien
Catherine
C
Cousens
Lois
L
D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D002214:Capsules; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010003:Osteoarthritis / Q000188:drug therapy* / Q000503:physiopathology*; D010166:Palliative Care / Q000379:methods; D013607:Tablets; D014147:Tramadol / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*
D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D013607:Tablets; D014147:Tramadol