An Open-Label, Randomized, 2-Way, Crossover Bioequivalence Study of Cefradine Capsules in Healthy Chinese Volunteers

Area of Science:

• Pharmacokinetics
• Clinical Pharmacology
• Drug Bioequivalence Studies

Background:

• Cefradine is an antibiotic commonly prescribed for bacterial infections.
• Establishing bioequivalence is crucial for generic drug approval and therapeutic interchangeability.

Purpose of the Study:

• To assess the bioequivalence of test cefradine capsules compared to a reference formulation.
• To evaluate bioequivalence under both fasted and fed conditions in healthy Chinese volunteers.

Main Methods:

• Open-label, randomized, biperiodic, crossover study design.
• Administration of single 250-mg doses of test or reference cefradine capsules.
• Pharmacokinetic sampling over 8 hours post-dose, with a 1-week washout period.

Main Results:

• Fasting study: 90% confidence intervals for Cmax, AUC(0-8h), and AUC(0-∞) were within bioequivalence limits.
• Fed study: 90% confidence intervals for Cmax, AUC(0-8h), and AUC(0-∞) were within bioequivalence limits.
• All key pharmacokinetic parameters fell within the accepted range for bioequivalence.

Conclusions:

• Test cefradine capsules are bioequivalent to the reference formulation.
• Bioequivalence is confirmed under both fasting and fed conditions.
• The findings support the interchangeability of the test and reference cefradine capsules.