title: Pharmacokinetic properties of tramadol sustained release capsules. 1st communication: investigation of dose linearity.
abstract: 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.
authors.affiliation: LAFAA Laboratory for Contract Research in Clinical Pharmacology, Bad Schwartau, Germany.
authors.forename: H U
authors.initials: HU
authors.lastname: Schulz
authors.forename: M
authors.initials: M
authors.lastname: Raber
authors.forename: M
authors.initials: M
authors.lastname: Schürer
authors.forename: S
authors.initials: S
authors.lastname: Amschler
authors.forename: H
authors.initials: H
authors.lastname: Momberger
mesh_terms: 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*
chemical_list: D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D014147:Tramadol