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Pharmacokinetics and bioequivalence studies of galantamine hydrobromide dispersible tablet in healthy male Chinese volunteers.
- Source :
-
Drug development and industrial pharmacy [Drug Dev Ind Pharm] 2007 Mar; Vol. 33 (3), pp. 335-40. - Publication Year :
- 2007
-
Abstract
- A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng/mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC(0-->t) (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC(0-->infinity) (the area under the plasma concentration-time curve from time 0 to infinity), t((1/2)) (elimination of half-life of the terminal log linear phase), C(max) (maximum plasma drug concentration) and T(max) (time to reach C(max)) were evaluated through noncompartmental pharmacokinetic analysis. AUC(0-->t) and AUC(0-->infinity) were calculated by the linear-log trapezoidal rule method. C(max) and T(max) were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC(0-->t), AUC(0-->infinity) and C(max). As far as AUC(0-->t), AUC(0-->infinity) and C(max) were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC(0-->t), AUC(0-->infinity) and C(max) values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC(0-->t), AUC(0-->infinity) and C(max) were entirely within 80-125%, two formulations were considered bioequivalent.
Details
- Language :
- English
- ISSN :
- 0363-9045
- Volume :
- 33
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Drug development and industrial pharmacy
- Publication Type :
- Academic Journal
- Accession number :
- 17454066
- Full Text :
- https://doi.org/10.1080/03639040600868011