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Related Experiment Videos

Comparative bioavailability study of two atenolol tablet preparations.

K K Peh1, K H Yuen, J W Wong

  • 1School of Pharmaceutical Sciences, University of Science Malaysia, Penang, Malaysia.

Drug Development and Industrial Pharmacy
|March 11, 1999
PubMed
Summary

This study found the generic atenolol (Normaten FC) to be bioequivalent to the innovator product (Tenormin). Bioavailability parameters, including AUC0-infinity and Cmax, showed no significant differences, confirming therapeutic equivalence.

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Area of Science:

  • Pharmacokinetics
  • Clinical Pharmacology
  • Drug Bioavailability

Background:

  • Atenolol is a widely prescribed beta-blocker for cardiovascular conditions.
  • Generic drug products must demonstrate bioequivalence to innovator products.
  • Normaten FC is a generic formulation of atenolol.

Purpose of the Study:

  • To compare the bioavailability of Normaten FC against the innovator product, Tenormin.
  • To establish bioequivalence between the generic and innovator atenolol formulations.

Main Methods:

  • Randomized, two-way crossover study design.
  • Inclusion of twelve healthy adult volunteers.
  • Pharmacokinetic analysis of area under the plasma concentration-time curve (AUC0-infinity), peak plasma concentration (Cmax), and time to reach peak plasma concentration (Tmax).

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Main Results:

  • No statistically significant differences in Tmax between Normaten FC and Tenormin.
  • Logarithmically transformed AUC0-infinity and Cmax values were comparable.
  • 90% confidence intervals for AUC0-infinity (0.82-0.98) and Cmax (0.82-1.09) fell within the bioequivalence range (0.80-1.25).
  • Elimination half-life (t1/2) values were statistically comparable.

Conclusions:

  • Normaten FC is bioequivalent to Tenormin.
  • The generic atenolol formulation is therapeutically equivalent to the innovator product.
  • This supports the use of Normaten FC as a cost-effective alternative to Tenormin.