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Details for article 6 of 6 found articles
| Title: |
Steady-state bioequivalence studies of two memantine tablet and oral solution formulations in healthy volunteers |
| Author: |
Jaroslav Chladek Borek Zaludek Petr Sova Ales Franc Ludek Sispera Jirina Martinkova Stanislav Micuda Jolana Cermanova |
| Appeared in: |
Journal of applied biomedicine |
| Paging: | Volume 6 (2007) nr. 1 pages 39-45 |
| Year: |
2007 |
| Contents: |
The bioavailability of memantine was compared using two tablet (Memantine LACHEMA 10 tbl. obd.and Akatinol® Memantine 10 tbl. obd., Study A) and two oral solution formulations (MemantineLACHEMA gtt. and Akatinol® Memantine gtt., Study B) containing 10 mg memantine hydrochloride intwo randomized, two-period, two-sequence, crossover studies with 24 healthy volunteers. In both studyperiods, memantine concentrations were determined by gas-chromatography with electron-capturedetection in plasma samples taken at the steady state after 22 days of once-daily dosing. The arithmeticmean (SD) pharmacokinetic parameters in the studies A and B were: AUC0-0τ,ss 768 (141) vs. 727 (99) and807 (154) vs. 836 (156) ng/ml h, Cmax,ss 37.3 (6.1) vs. 35.2 (4.5) and 39.2 (7.3) vs. 40.6 (6.7) ng/ml.Median values of Tmax were in the range of 4 to 5 h. Both tablet and oral solution formulations were foundbioequivalent (90%-confidence intervals for AUC0-τ,ss, Cmax,ss and Cτ,ss within 101–114% (Study A) and 92and 104% (Study B)). For the peak-trough fluctuation, the bioequivalence intervals were 85–107% and86–04%, respectively. By pooled analysis of both studies, the geometric mean (90% CI) relativebioavailability of memantine from tablets compared to oral solutions was 91% (85–98). |
| Publisher: |
University of South Bohemia (provided by DOAJ) |
| Source file: |
Elektronische Wetenschappelijke Tijdschriften |
Details for article 6 of 6 found articles
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