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Bioequivalence of tolbutamide-containing tablet preparations
International Journal of Clinical Pharmacology and Therapeutics
|January 1, 1997
Summary
Two tolbutamide preparations were found to be bioequivalent in a crossover study involving 22 volunteers. Plasma tolbutamide concentrations measured over 48 hours confirmed similar pharmacokinetic profiles for both formulations.
Area of Science:
- Pharmacokinetics
- Clinical Pharmacology
- Drug Bioequivalence Studies
Background:
- Tolbutamide is an oral hypoglycemic agent used in type 2 diabetes management.
- Assessing bioequivalence of different drug formulations is crucial for therapeutic interchangeability.
- Previous studies may not have definitively compared these specific tolbutamide preparations.
Purpose of the Study:
- To determine the bioequivalence of two tolbutamide tablet preparations (tolbutamide R.A.N. vs. rastinon Hoechst).
- To compare plasma tolbutamide concentrations and pharmacokinetic parameters after single-dose administration.
Main Methods:
- A randomized, two-treatment, crossover study design was employed.
- 22 healthy volunteers received a single 1g dose of each tolbutamide preparation.
- Plasma tolbutamide concentrations were quantified using High-Performance Liquid Chromatography (HPLC) over 48 hours.
Main Results:
- Mean Area Under the Curve (AUC0-48) values were nearly identical (998.42 vs. 997.73 µg*h/mL).
- Peak plasma concentration (Cmax) and time to peak concentration (tmax) showed minor variations within acceptable bioequivalence limits.
- Westlake confidence intervals for AUC and Cmax fell within the accepted bioequivalence range (0.972-1.046 for AUC, 0.896-0.978 for Cmax).
Conclusions:
- The two tolbutamide tablet preparations are bioequivalent.
- The observed differences in Cmax and tmax are not clinically significant for maintenance therapy.
- This study supports the interchangeability of tolbutamide R.A.N. and rastinon Hoechst formulations.