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Bioequivalence study of two amoxicillin formulations
Eman AlGaai1, Saleh AlDigither, Marilyn Lockyer
1Centre for Clinical Research, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
Arzneimittel-Forschung
|February 16, 2006
Summary
This study compared two amoxicillin formulations, finding the Glomox tablet and amoxicillin capsule to be bioequivalent. The results indicate comparable absorption rates and extents for both amoxicillin products.
Area of Science:
- Pharmacokinetics
- Pharmaceutical Sciences
- Drug Bioavailability
Background:
- Amoxicillin is a widely used antibiotic.
- Evaluating the bioavailability of generic drug formulations is crucial for therapeutic equivalence.
- Glomox tablet is a new amoxicillin formulation requiring comparison with a reference product.
Purpose of the Study:
- To compare the bioavailability of a Glomox tablet (test) formulation against a standard amoxicillin capsule (reference) formulation.
- To determine pharmacokinetic parameters and assess bioequivalence between the two amoxicillin products.
Main Methods:
- A randomized, single-dose, crossover study in 24 healthy male volunteers.
- Administration of 1000 mg of each amoxicillin formulation after an overnight fast.
- Serum amoxicillin concentrations analyzed using high-performance liquid chromatography (HPLC) with non-compartmental pharmacokinetic analysis.
Main Results:
- Key pharmacokinetic parameters including Cmax, Tmax, AUC0-->t, AUC0-->infinity, and t1/2 were comparable between the Glomox tablet and amoxicillin capsule.
- Parametric 90% confidence intervals for the differences in log-transformed AUC and Cmax values fell within the accepted bioequivalence range (80-125%).
Conclusions:
- The Glomox tablet and the reference amoxicillin capsule formulation are bioequivalent.
- The two amoxicillin formulations demonstrate comparable rate and extent of absorption under fasting conditions, supporting their interchangeable use.