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Published on: January 18, 2017
[Study on relative bioavailability of aspirin in afenca tablet]
Junyi Yang1, Xuehua Jiang, Lin He
1School of Pharmacy, Sichuan University, Chengdu 610041.
This study found Afenca test and reference preparations containing salicylic acid to be bioequivalent. Plasma concentration analysis confirmed comparable bioavailability for both formulations.
Area of Science:
- Pharmacokinetics
- Analytical Chemistry
- Biopharmaceutics
Context:
- Salicylic acid is a key active metabolite of aspirin.
- Assessing the bioavailability of drug formulations is crucial for therapeutic equivalence.
- Oral administration of aspirin-containing products requires rigorous pharmacokinetic evaluation.
Purpose:
- To determine the relative bioavailability of salicylic acid from Afenca test and reference preparations.
- To evaluate the bioequivalence of two oral formulations based on salicylic acid pharmacokinetics.
- To compare plasma concentration profiles of salicylic acid after single-dose administration.
Summary:
- Twenty-four healthy male volunteers received single oral doses of Afenca test and reference preparations.
- Plasma salicylic acid concentrations were measured using reversed-phase high-performance liquid chromatography (RP-HPLC).
- Statistical analysis (ANOVA, t-tests) indicated the preparations are bioequivalent, with relative bioavailability of 105.36% +/- 14.15%.
Impact:
- Establishes bioequivalence between Afenca test and reference formulations.
- Provides pharmacokinetic data supporting the interchangeability of these aspirin-related products.
- Contributes to the understanding of salicylic acid metabolism and drug formulation assessment.
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Bioavailability: Overview
Bioavailability: Overview
Bioavailability: Influencing Factors
Bioavailability Study Design: Absolute Versus Relative Bioavailability
Bioavailability Study Design: Single Versus Multiple Dose Studies
Bioavailability Study Design: Healthy Subjects Versus Patients

