Human Bioequivalence Study of Clarithromycin from Two Tablet Formulations after Single Oral Administration

Area of Science:

• Pharmacokinetics
• Drug bioavailability
• Bioequivalence studies

Background:

• Clarithromycin is a widely used antibiotic.
• Assessing the bioequivalence of generic drug formulations is crucial for therapeutic interchangeability.
• Understanding drug absorption characteristics is essential for effective treatment.

Purpose of the Study:

• To compare the relative bioavailability and bioequivalence of Claromycin® (test) and Klaricid® (reference) 500mg clarithromycin tablets.
• To evaluate the rate and extent of absorption of the two clarithromycin formulations in healthy volunteers.

Main Methods:

• A nonblinded, randomized, two-period crossover study was conducted in 16 healthy volunteers.
• Participants were administered single doses of 500mg clarithromycin under fasting conditions.
• Plasma clarithromycin concentrations were analyzed using high-performance liquid chromatography with electrochemical detection.

Main Results:

• The 90% confidence intervals for the test/reference ratio of AUC0-∞, AUC0-t, and Cmax were within the accepted bioequivalence range (80-125%).
• Point estimates for AUC0-∞, AUC0-t, and Cmax were 97.3%, 98.3%, and 103.1%, respectively.
• No statistically significant differences were observed in Tmax and elimination half-life between the two formulations.

Conclusions:

• Claromycin® and Klaricid® 500mg clarithromycin tablets are bioequivalent.
• The rate and extent of absorption are comparable between the test and reference formulations.
• This supports the potential for therapeutic interchangeability between the two clarithromycin products.