Related Experiment Video
Updated: Jun 21, 2026

Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs
Published on: December 9, 2010
Pharmacokinetic study and comparative bioavailability of two nelfinavir tablet formulations in Iranian healthy
1Department of Pharmaceutics, Faculty of Pharmacy, Kermanshah University of Medical Scinences, Kermanshah, Iran. kderakhshandeh@kums.ac.ir
Abstract:
The objective of this study is to evaluate pharmacokinetic parameters, bioavailability of a potent HIV protease inhibitor, nelfinavir mesylate (NFV), following a single oral administration of 2 tablet formulations. A randomized, 2-way, crossover, bioequivalence study was conducted in 24 healthy male volunteers to compare 2 brands of nelfinavir 250 mg tablets, Nelfabiovir (Bakhtar Bioshimi, Iran) as test and Viracept (Roche, Germany) as reference product. Blood samples were collected at selected times during 12 h and plasma concentrations were determined with a sensitive and validated HPLC method involving a simple protein precipitation step. Individual pharmacokinetic parameters, t1/2, t1/2(abs), K, Ka, tmax, Cmax, Vd/F, Cl/F, AUC0-12 and AUC0- yen were determined from plasma concentration-time profiles for both formulations and were compared statistically. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range, satisfying the bioequivalence criteria of the FDA. In vitro parameters of mean dissolution time (MDT) and time for 70% dissolution (T70) were also determined. There was no significant difference between these parameters for two dosage forms (p > 0.05). It was concluded that the two nelfinavir products are bioequivalent with respect to the rate and extent of absorption.
More Related Videos
10:29Quantitative Structure-Activity Relationship, Activity Prediction, and Molecular Dynamics of Non-nucleotide Reverse Transcriptase Inhibitors
Published on: May 9, 2025
09:24Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Related Concept Videos
Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability Study Design: Single Versus Multiple Dose Studies
Modified-Release Drug Delivery Systems: Bioavailability
Bioavailability Study Design: Absolute Versus Relative Bioavailability
Bioavailability: Overview
Bioavailability: Overview