metabolite parameters as an appropriate alternative approach for assessment of bioequivalence of two verapamil formulations

Authors

azadeh haeri shahid beheshti university of medical sciences

bahareh javadian shahid beheshti university of medical sciences

roonak saadati shahid beheshti university of medical sciences

simin dadashzadeh shahid beheshti university of medical sciences

abstract

a bioequivalence study of two verapamil formulations (generic verapamil tablets and isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. moreover, the feasibility of proving bioequivalence of verapamil oral dosing form by means of norverapamil pharmacokinetic parameters was evaluated. concentrations of verapamil and norverapamil were quantified in plasma using a validated high-performance liquid chromatography (hplc) with fluorescence detection. the 90% cis for the log-transformed ratios of verapamil cmax and auc0–∞ were 73 to 101 and 80 to 103, respectively. similarly, the corresponding ranges for norverapamil were 80-100 and 84-103, respectively. according to the parent drug data, the 90% confidence intervals around the geometric mean ratio of auc happened to fit within preset bioequivalence limits of 80–125%, whereas those for cmax did not. the 90% confidence intervals for both cmax and auc of norverapamil met preset bioequivalence limits. the auc and cmax of metabolite, when compared to parent drug, showed a much lower degree of variability and the 90% confidence intervals of the metabolite were therefore narrower than those of the parent drug. these observations indicate that bioequivalence studies using metabolite, norverapamil, could be a more suitable and preferable approach to assess bioequivalence of verapamil formulations due to its much lower variability and therefore lower number of volunteers that are required to conduct the study.

Upgrade to premium to download articles

Sign up to access the full text

Already have an account?login

similar resources

Metabolite Parameters as an Appropriate Alternative Approach for Assessment of Bioequivalence of Two Verapamil Formulations

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibili...

full text

Metabolite Parameters as an Appropriate Alternative Approach for Assessment of Bioequivalence of Two Verapamil Formulations

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibili...

full text

Metabolite Parameters as an Appropriate Alternative Approach for Assessment of Bioequivalence of Two Verapamil Formulations

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin(®) tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibi...

full text

the use of appropriate madm model for ranking the vendors of mci equipments using fuzzy approach

abstract nowadays, the science of decision making has been paid to more attention due to the complexity of the problems of suppliers selection. as known, one of the efficient tools in economic and human resources development is the extension of communication networks in developing countries. so, the proper selection of suppliers of tc equipments is of concern very much. in this study, a ...

15 صفحه اول

Bioequivalence assessment of two formulations of ibuprofen

BACKGROUND This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz(®), produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen(®), manufactured by Boots Company, Nottingham, UK. METHODS AND RESULTS A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precis...

full text

My Resources

Save resource for easier access later


Journal title:
iranian journal of pharmaceutical research

جلد ۱۳، شماره ۲، صفحات ۳۸۳-۳۹۱

Hosted on Doprax cloud platform doprax.com

copyright © 2015-2023