Bioequivalency of three tableted gallopamil products.
A three cross-study was conducted in 12 healthy male volunteers to evaluate the relative bioavailability of three different gallopamil tablets: Product A-Galcan 25 mg, Product B-Galcan 50 mg and Product C-Procorum 50 mg. Each dose was administered as a single tablet after an overnight fast, and blood samples were obtained for 12 hours. There was no statistically significant differences among the three products for the mean area under the plasma concentration-time curves (when corrected for the different doses). The relative bioavailability of Product A and B to Product C was respectively 96.3% (ESM = 12.4%) and 103.1% (ESM = 10.2%). Statistically significant (p less than 0.05) differences were found in Tmax between Product C (1.0 hr) and both Product A (2.1 hr) and Product B (2.4 hr). A longer-lasting absorption should always diminish peak to trough fluctuations during multiple dosing and to this extent Product B has some advantage over Product C.
Regazzi
M B
MB
Molinaro
M
M
Daneri
A
A
Tizzoni
M
M
Legnazzi
P
P
D000328:Adult; D002851:Chromatography, High Pressure Liquid; D005711:Gallopamil / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006207:Half-Life; D006801:Humans; D008297:Male; D013810:Therapeutic Equivalency
D005711:Gallopamil