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[Importance of the formulation for a chronopharmacologically optimised way of pain therapy. Results of a comparative bioavailability study of tramadol extended-release capsules after single-dose evening versus morning administration]. / Bedeutung der Galenik in der "chrono- adjustierten" Schmerzbehandlung. Ergebnisse einervergleichenden Bioverfügbarkeitsuntersuchung mit einem Tramadol- Retardpräparat nach Einmalgabe am Abend und am Morgen.
Warnke, A; Schug, B; Vanderbist, F; Blume, H.
Affiliation
  • Warnke A; SocraTec R&D GmbH, Oberursel
MMW Fortschr Med ; 150 Suppl 1: 36-42, 2008 Apr 10.
Article in De | MEDLINE | ID: mdl-18540331
ABSTRACT
UNLABELLED Objective of this study was to investigate the rate and extent of tramadol bioavailability following evening versus morning administration.

METHODS:

The study was performed following an open, randomised, cross-over study-design. 18 male and female volunteers were enrolled into the study and treated with 200 mg tramadol extended-release capsules (T-long), which were to be taken either in the morning or in the evening.

RESULTS:

Plasma concentration versus time profiles obtained after morning and evening administration were almost superimposable for both, tramadol and its active metabolite. Maximum exposure of tramadol and O-desmethyltramadol (geometric means of c(max)-values) as well as extent of exposure (geometric means of AUC(0-48)-values) were comparable after morning and eveningadministration.

CONCLUSIONS:

Time-point of administration does not have any relevant impact on the rate and extent of absorption in the investigated dosage form. Thus, time-point of administration may be adjusted to the patient's need in a chronopharmacologically optimised way for pain therapy.
Subject(s)
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Collection: 01-internacional Database: MEDLINE Main subject: Pain / Tramadol / Analgesics, Opioid Type of study: Clinical_trials Limits: Adult / Female / Humans / Male / Middle aged Language: De Journal: MMW Fortschr Med Journal subject: MEDICINA Year: 2008 Document type: Article
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Collection: 01-internacional Database: MEDLINE Main subject: Pain / Tramadol / Analgesics, Opioid Type of study: Clinical_trials Limits: Adult / Female / Humans / Male / Middle aged Language: De Journal: MMW Fortschr Med Journal subject: MEDICINA Year: 2008 Document type: Article