Pharmacokinetic properties of tramadol sustained release capsules. 1st communication: investigation of dose linearity.
The relationship between the dose and the pharmacokinetic characteristics. AUC(0-infinity) and Cmax was investigated with respect to linearity in 12 healthy male volunteers. Single doses of 50 mg, 100 mg and 200 mg tramadol (CAS 27203-92-5) hydrochloride were administered as sustained release capsules in an open, randomized three-period crossover study. Tramadol plasma concentrations were determined by a validated gas chromatography method. Statistical analysis after logarithmic transformation of the dose-adjusted characteristics mentioned above yielded bioequivalence for all doses applied. Therefore, dose linearity for the range investigated could be concluded.
Schulz
H U
HU
LAFAA Laboratory for Contract Research in Clinical Pharmacology, Bad Schwartau, Germany.
Raber
M
M
Schürer
M
M
Amschler
S
S
Momberger
H
H
D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002214:Capsules; D002849:Chromatography, Gas; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D006801:Humans; D008297:Male; D014147:Tramadol / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*
D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D014147:Tramadol