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Related Experiment Videos

Comparative bioavailability study of a generic naltrexone tablet preparation.

K H Yuen1, K K Peh, N Billa

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

Drug Development and Industrial Pharmacy
|March 11, 1999
PubMed
Summary
This summary is machine-generated.

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This study compared the bioavailability of generic naltrexone (Narpan) to the original Trexan. Results show Narpan is bioequivalent to Trexan, indicating comparable efficacy and safety for naltrexone formulations.

Area of Science:

  • Pharmacokinetics
  • Pharmaceutical Sciences
  • Clinical Pharmacology

Background:

  • Naltrexone is an opioid antagonist used in addiction treatment.
  • Generic drug development requires demonstrating bioequivalence to innovator products.
  • Narpan is a generic preparation of naltrexone.

Purpose of the Study:

  • To compare the bioavailability of generic naltrexone (Narpan) with the innovator product (Trexan).
  • To establish bioequivalence between Narpan and Trexan.

Main Methods:

  • A randomized, two-way crossover study involving 12 healthy volunteers.
  • Pharmacokinetic parameters including Area Under the Curve (AUC0-infinity), Peak Plasma Concentration (Cmax), and Time to Peak Concentration (Tmax) were measured.
  • Statistical analysis included logarithmic transformation and 90% confidence intervals.

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Main Results:

  • No statistically significant differences were found in logarithmic transformed AUC0-infinity and Cmax between Narpan and Trexan.
  • Untransformed Tmax values also showed no significant differences.
  • The 90% confidence intervals for AUC0-infinity (0.87-1.01) and Cmax (0.94-1.23) fell within the bioequivalence range (0.80-1.25).
  • Elimination half-life (t1/2) was comparable between the two preparations.

Conclusions:

  • Narpan is bioequivalent to Trexan.
  • The generic naltrexone preparation demonstrates comparable pharmacokinetic profiles to the innovator product.
  • This supports the use of Narpan as a therapeutically equivalent alternative to Trexan.