Bioequivalence assessment of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK)--Two brands of Acyclovir--in healthy human volunteers.
Two studies were performed to assess the relative bioavailability of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved acyclovir tablets and the other acyclovir suspension. Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of acyclovir were administered as a single dose on 2 treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 16 h. Plasma harvested from blood, was analysed for acyclovir by an HPLC method with UV detection. Various pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2 and Kelm were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC0-t, AUC(0-proportional to), and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals for the test/reference ratio of these parameters were found within the bioequivalence acceptance range 80%-125%. Based on these statistical inferences it was concluded that a Lovrak tablet is bioequivalent to a Zovirax tablet and that Lovrak suspension is bioequivalent to Zovirax suspension.
Najib
Naji M
NM
International Pharmaceutical Research Centre, Amman, Jordan.
Idkaidek
Nasir
N
Beshtawi
Muntaser
M
Mohammed
B
B
Admour
Isra'
I
Alam
S Mahmood
SM
Dham
Ruwayda
R
D000212:Acyclovir / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D004345:Drug Industry; D016568:Drugs, Generic / Q000493:pharmacokinetics*; D006207:Half-Life; D006801:Humans; D008297:Male; D004364:Pharmaceutical Preparations; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards; D013810:Therapeutic Equivalency
D016568:Drugs, Generic; D004364:Pharmaceutical Preparations; D000212:Acyclovir