Bioequivalence of Two Brands of Ciprofloxacin 750 Mg Tablets (Sarf® and Ciprobay®) in Healthy Human Volunteers

ABSTRACT

An open, randomized, two-way crossover study was carried out in 28 healthy volunteers at Gulf Pharmaceutical Industries (Julphar), as a joint venture with Saqr Hospital, Ras Al-Khaimah, UAE. The two commercial brands used were Sarf® (Julphar, UAE) as test and Ciprobay® (Bayer AG, Germany) as reference product. The drug was administered to each subject with 240 mL of water after an overnight fasting in two treatment days separated by a one-week washout period. After dosing, serial blood samples were collected for a period of 24 hr and serum was separated and analyzed for ciprofloxacin using a sensitive, reproducible, and accurate high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection. Various pharmacokinetic parameters, including AUC_0–t, AUC_0–∞, C_max, T_max, t_1/2, and λ_Z, were determined from ciprofloxacin serum concentration–time profiles for both formulations and found to be in good agreement with reported values. The parameters AUC_0–t, AUC_0–∞, and C_max were tested for bioequivalence after log-transformation of data. No significant difference was found based on analysis of variance (ANOVA); the 90% confidence intervals (95.73–107.62%, 94.98–108.26%, 92.80–103.90% for AUC_0–t, AUC_0–∞, C_max, respectively) for the test/reference ratios of these parameters were within the bioequivalence acceptance range of 80–125%. Based on this data, it is concluded that both formulations are bioequivalent and are interchangeable in medical practice.

• Bioequivalence
• Ciprofloxacin
• Healthy human volunteers
• HPLC analysis