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Bioequivalence assessment of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK)-Two brands of Acyclovir-in healthy human volunteers

✍ Scribed by Naji M. Najib; Nasir Idkaidek; Muntaser Beshtawi; B. Mohammed; Isra' Admour; S. Mahmood Alam; Ruwayda Dham; Qumaruzaman


Book ID
101702058
Publisher
John Wiley and Sons
Year
2005
Tongue
English
Weight
83 KB
Volume
26
Category
Article
ISSN
0142-2782

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✦ Synopsis


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 AUC 0Àt , AUC 0À1 , C max , T max , T 1/2 and K elm were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC 0Àt , AUC 0À/, and C max were tested for bioequivalence after logtransformation 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.


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