Bioavailability of diclofenac potassium at low doses
Publikation: Beitrag in Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung
Beitragende
Abstract
Aim: Diclofenac-K has been recently launched at low oral doses in different countries for over-the-counter use. However, given the considerable first-pass metabolism of diclofenac, the degree of absorption of diclofenac-K at low doses remained to be determined. The aim of this study was to determine the bioavailability of low-dose diclofenac-K. Methods: A randomized, three-way, cross-over study was performed in 10 subjects. Each received diclofenac-K, 22.5 mg via short-term i.v. infusion and orally at single doses of 12.5 mg and 25 mg. Results: Mean (± SD) times to maximal plasma concentration (t max) of diclofenac were 0.48 ± 0.28 h (12.5 mg) and 0.93 ± 0.96 h (25 mg). The absolute bioavailability of diclofenac-K after oral administration did not differ significantly in the 12.5-mg and 25-mg dose group (63.1 ± 12.6% vs. 65.1 ± 19.4%, respectively). The 90% confidence intervals for the AUC∞ and AUCt ratios for the two oral regimes were 82.6, 103.4% (point estimate 92.4%) and 86.2, 112.9% (point estimate 98.6%), respectively. These values were within the acceptance criteria for bioequivalence (80-125%). Conclusions: Our data indicate that diclofenac-K is rapidly and well absorbed at low dose, and are consistent with a rapid onset of action of the drug.
Details
Originalsprache | Englisch |
---|---|
Seiten (von - bis) | 80-84 |
Seitenumfang | 5 |
Fachzeitschrift | British Journal of Clinical Pharmacology |
Jahrgang | 59 |
Ausgabenummer | 1 |
Publikationsstatus | Veröffentlicht - Jan. 2005 |
Peer-Review-Status | Ja |
Externe IDs
PubMed | 15606444 |
---|---|
ORCID | /0000-0003-0845-6793/work/139025231 |
Schlagworte
ASJC Scopus Sachgebiete
Schlagwörter
- Bioavailability, Diclofenac, Pharmacokinetics, Potassium salt