Golestan University of Medical Sciences Repository

Lack of bioequivalence between two aciclovir tablets in healthy subjects

Amini, H. and Javan, M. and Gazerani, P. and Ghaffari, A. and Ahmadiani, A. (2008) Lack of bioequivalence between two aciclovir tablets in healthy subjects. Clinical Drug Investigation, 28 (1). pp. 47-53. ISSN 11732563 (ISSN)

[img] PDF - Published Version
Restricted to Repository staff only

Download (114kB)

Abstract

Objective: This study aimed to compare the systemic bioavailability of two aciclovir tablets, Rouz-Aciclovir (test) and Zovirax® (reference), in 12 healthy volunteers. Methods: In a crossover design, each subject received a single oral dose of aciclovir 400 mg followed by a 7-day washout period. Plasma concentrations of aciclovir were measured for up to 12 hours using a validated high-performance liquid chromatography method with a lower limit of quantification of 50 μg/L. Results: The mean values of maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from time 0 to 12 hours (AUC12) and from time 0 to infinity (AUC∞), and plasma half-life following administration of the test product were 999.6 μg/L, 2.08 h, 4911.2 μg/L • h, 5417.7 μg/L • h and 3.08 h, respectively, and for the reference product 775.8 μg/L, 2.58 h, 3862.1 μg/L • h, 4295.4 μg/L • h and 3.14 h, respectively. The test/reference geometric ratio for Cmax (90% CI) was 1.30 (97.1, 174.8). The test/reference geometric ratios for AUC12 (90% CI) and AUC∞ (90% CI) were 1.26 (99.7, 159.1) and 1.24 (98.9, 155.6), respectively. Therefore, the 90% CIs of Cmax, AUC12 and AUC∞ were not within the acceptable range of 80 and 125 suggested by the US FDA bioequivalence guideline. Conclusion: The results of the present study suggest that the aciclovir test product was not bioequivalent to the reference product. The exact reasons for this remain to be determined. However, we think the difference should be attributed to the difference in the type and amounts of ingredients used in the formulation that probably affect the contact time of aciclovir with the sites of absorption in the gut. © 2008 Adis Data Information BV. All rights reserved.

Item Type: Article
Additional Information: Unmapped bibliographic data: LA - English [Field not mapped to EPrints] J2 - Clin. Drug Invest. [Field not mapped to EPrints] C2 - 18081360 [Field not mapped to EPrints] AD - Department of Physiology and Pharmacology, Cardiovascular Research Center, Golestan University of Medical Sciences, Gorgan, Iran [Field not mapped to EPrints] AD - Department of Pharmacology, Neuroscience Research Center, Shaheed Beheshti University (Medical Sciences), Tehran, Iran [Field not mapped to EPrints] AD - Department of Physiology, School of Medical Sciences, Tarbiat Modares University, Tehran, Iran [Field not mapped to EPrints] AD - International Doctoral School in Biomedical Science and Engineering, Aalborg University, Center for Sensory-Motor Interaction, Aalborg, Denmark [Field not mapped to EPrints] AD - Research and Development Center, Rouzdaru Pharmaceutical Company, Tehran, Iran [Field not mapped to EPrints] AD - Department of Physiology and Pharmacology, Cardiovascular Research Center, Golestan University of Medical Sciences, PO Box 49175-553, Gorgan, Iran [Field not mapped to EPrints] DB - Scopus [Field not mapped to EPrints]
Uncontrolled Keywords: Aciclovir, pharmacokinetics, Bioequivalence, aciclovir, rouz aciclovir, unclassified drug, adult, area under the curve, article, bioequivalence, blood sampling, comparative study, controlled study, drug absorption, drug bioavailability, drug formulation, drug tolerance, high performance liquid chromatography, human, male, maximum plasma concentration, normal human, priority journal, single drug dose, tablet formulation, time to maximum plasma concentration, Acyclovir, Administration, Oral, Adult, Analysis of Variance, Antiviral Agents, Area Under Curve, Biological Availability, Chromatography, High Pressure Liquid, Cross-Over Studies, Half-Life, Humans, Least-Squares Analysis, Male, Metabolic Clearance Rate, Tablets, Therapeutic Equivalency
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 18 Apr 2015 03:33
Last Modified: 15 Feb 2017 04:57
URI: http://eprints.goums.ac.ir/id/eprint/2349

Actions (login required)

View Item View Item