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Pharmacokinetics of dexibuprofen administered as 200 mg and 400 mg film-coated tablets in healthy volunteers.
Int J Clin Pharmacol Ther. 1998 Aug; 36(8):414-7.IJ

Abstract

The pharmacokinetic properties of 2 film-coated preparations containing 200 mg and 400 mg dexibuprofen were compared in a single-dose, crossover study in 16 healthy, male volunteers. Dexibuprofen was absorbed rapidly (tmax 2.1 - 2.2 hours) reaching maximum concentrations of 12.4 microg/ml (200 mg), respectively 12.0 microg/ml (400 mg dose adjusted). For the characteristics AUC(0-12h) and AUC(0-infinity) arithmetic means of 49.2 (microg) x (h/ml)(200 mg) and 48.2 (microg) x (h/ml)(400 mg dose-adjusted), respectively 50.5 (microg) x (h/ml)(200 mg), and 49.2 (microg) x (h/ml)(400 mg) were calculated. No relevant differences for the pharmacokinetic characteristics terminal half-life, clearance, volume of distribution, and mean residence time were observed. A linear dose-relationship was shown over the investigated dose range. Mean ratios after dosage adjustment of the test preparation using the "2 one-sided t-tests" procedure were calculated. Bioequivalence was assessed for AUC(0-12h) with a mean ratio of 97.7% (90% CI: 92.4 - 103.3%), for AUC(0-infinity) with 97.1% (90% CI: 91.4 - 103.1%), and for Cmax with 97.5% (90% CI: 91.7 - 103.8%). Both dexibuprofen preparations were well tolerated. No changes in hematological and biochemical parameters were detected.

Authors+Show Affiliations

Medical Department, Gebro Broschek GmbH, Fieberbrunn, Austria.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Controlled Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9726693

Citation

Eller, N, et al. "Pharmacokinetics of Dexibuprofen Administered as 200 Mg and 400 Mg Film-coated Tablets in Healthy Volunteers." International Journal of Clinical Pharmacology and Therapeutics, vol. 36, no. 8, 1998, pp. 414-7.
Eller N, Kollenz CJ, Schiel H, et al. Pharmacokinetics of dexibuprofen administered as 200 mg and 400 mg film-coated tablets in healthy volunteers. Int J Clin Pharmacol Ther. 1998;36(8):414-7.
Eller, N., Kollenz, C. J., Schiel, H., Kikuta, C., & Mascher, H. (1998). Pharmacokinetics of dexibuprofen administered as 200 mg and 400 mg film-coated tablets in healthy volunteers. International Journal of Clinical Pharmacology and Therapeutics, 36(8), 414-7.
Eller N, et al. Pharmacokinetics of Dexibuprofen Administered as 200 Mg and 400 Mg Film-coated Tablets in Healthy Volunteers. Int J Clin Pharmacol Ther. 1998;36(8):414-7. PubMed PMID: 9726693.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetics of dexibuprofen administered as 200 mg and 400 mg film-coated tablets in healthy volunteers. AU - Eller,N, AU - Kollenz,C J, AU - Schiel,H, AU - Kikuta,C, AU - Mascher,H, PY - 1998/9/3/pubmed PY - 1998/9/3/medline PY - 1998/9/3/entrez SP - 414 EP - 7 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 36 IS - 8 N2 - The pharmacokinetic properties of 2 film-coated preparations containing 200 mg and 400 mg dexibuprofen were compared in a single-dose, crossover study in 16 healthy, male volunteers. Dexibuprofen was absorbed rapidly (tmax 2.1 - 2.2 hours) reaching maximum concentrations of 12.4 microg/ml (200 mg), respectively 12.0 microg/ml (400 mg dose adjusted). For the characteristics AUC(0-12h) and AUC(0-infinity) arithmetic means of 49.2 (microg) x (h/ml)(200 mg) and 48.2 (microg) x (h/ml)(400 mg dose-adjusted), respectively 50.5 (microg) x (h/ml)(200 mg), and 49.2 (microg) x (h/ml)(400 mg) were calculated. No relevant differences for the pharmacokinetic characteristics terminal half-life, clearance, volume of distribution, and mean residence time were observed. A linear dose-relationship was shown over the investigated dose range. Mean ratios after dosage adjustment of the test preparation using the "2 one-sided t-tests" procedure were calculated. Bioequivalence was assessed for AUC(0-12h) with a mean ratio of 97.7% (90% CI: 92.4 - 103.3%), for AUC(0-infinity) with 97.1% (90% CI: 91.4 - 103.1%), and for Cmax with 97.5% (90% CI: 91.7 - 103.8%). Both dexibuprofen preparations were well tolerated. No changes in hematological and biochemical parameters were detected. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/9726693/Pharmacokinetics_of_dexibuprofen_administered_as_200_mg_and_400_mg_film_coated_tablets_in_healthy_volunteers_ DB - PRIME DP - Unbound Medicine ER -