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Comparative bioavailability study with two gemfibrozil tablet formulations in healthy volunteers
Ney Carter do C Borges1, Gustavo Duarte Mendes, Rafael E Barrientos-Astigarraga
1Department of Pharmacology, State University of Campinas, Campinas, SP, Brazil.
Arzneimittel-Forschung
|August 6, 2005
Summary
This study found the EMS Farmaceutica gemfibrozil 900 mg tablet to be bioequivalent to the reference formulation. Pharmacokinetic parameters confirmed comparable absorption rates and extents in healthy volunteers.
Area of Science:
- Pharmacokinetics
- Drug Bioequivalence Studies
- Analytical Chemistry
Background:
- Gemfibrozil is a lipid-regulating agent.
- Bioequivalence studies are crucial for generic drug approval.
- Assessing the pharmacokinetic profile of generic formulations ensures therapeutic equivalence.
Purpose of the Study:
- To evaluate the bioequivalence of a 900 mg gemfibrozil tablet (EMS Farmaceutica) compared to a reference formulation.
- To determine if the test formulation exhibits comparable pharmacokinetic parameters to the reference.
Main Methods:
- An open-label, randomized, two-period crossover study was conducted in 36 healthy volunteers.
- Plasma gemfibrozil concentrations were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS-MS).
- Key pharmacokinetic parameters including Cmax, AUClast, and AUC(0-inf) were determined.
Main Results:
- The 90% confidence intervals for the ratios of Cmax, AUClast, and AUC(0-inf) were within the acceptable bioequivalence range (80-125%).
- Specific ratios were: Cmax 90.29% (81.39-100.17%), AUClast 96.26% (90.33-102.59%), and AUC(0-infinity) 96.62% (90.82-102.78%).
Conclusions:
- The gemfibrozil 900 mg tablet (test formulation) is bioequivalent to the reference formulation.
- Bioequivalence was demonstrated for both the rate and extent of drug absorption.
- The findings support the therapeutic equivalence of the test formulation for clinical use.