Pharmacokinetic properties of tramadol sustained release capsules. 3rd communication: investigation of relative bioavailability under steady state conditions.
In an open, randomized two-period crossover study in 24 healthy male volunteers multiple doses of tramadol (CAS 27203-92-5) test and reference medication were administered as follows: Test: sustained release capsules containing 100 mg tramadol hydrochloride, a total of 6 capsules at intervals of 12 h; Reference: instant release capsules containing 50 mg tramadol hydrochloride, a total of 12 capsules at intervals of 6 h. As a result of the statistical analysis of AUCss(48-72 h) after logarithmic transformation a bioavailability of 100% for the sustained release capsules compared with the instant release capsules was obtained. As expected statistical analysis of the peak trough fluctuation at steady state PTFss(48-72 h) yielded a distinct diminution of the fluctuation.
Raber
M
M
Temmler Pharma GmbH, Marburg, Germany.
Schulz
H U
HU
Schürer
M
M
Krupp
S
S
Momberger
H
H
D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D014147:Tramadol / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*
D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D014147:Tramadol