Bioequivalence evaluation of two brands of enalapril 20 mg tablets (Narapril and Renitec) in healthy human volunteers.
The bioequivalence of two brands of enalapril 20 mg tablets was demonstrated in 24 healthy human volunteers after a single oral dose in a randomized cross-over study, conducted at IPRC, Amman, Jordan. Reference (Renitec, MSD, Netherlands) and test (Narapril, Julphar, UAE) products were administered to fasted male volunteers; blood samples were collected at specified time intervals, plasma separated and analysed for enalapril and its active metabolite (enalaprilat) using a validated LC-MS/MS method at Cartesius Analytical Unit, Institute of Biomedical Sciences, USP, Sao Paulo, Brazil. The pharmacokinetic parameters AUC(0-t), AUC(0-infinity), Cmax, Tmax, T(1/2) and elimination rate constant were determined from plasma concentration-time profile for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Julphar's Narapril is bioequivalent to Renitec of MSD, Netherlands.
Najib
Naji M
NM
International Pharmaceutical Research Centre (IPRC), Amman, Jordan.
Idkaidek
Nasir
N
Adel
Ayman
A
Admour
Isra'
I
Astigarraga
Rafel E B
RE
De Nucci
Gliberto
G
Alam
S Mahmood
SM
Dham
Ruwayda
R
Qumaruzaman
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004656:Enalapril / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D013608:Tablets, Enteric-Coated; D013810:Therapeutic Equivalency
D013608:Tablets, Enteric-Coated; D004656:Enalapril