Bioequivalence of two brands of ciprofloxacin 750 mg tablets (Sarf and Ciprobay) in healthy human volunteers.
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 AUC0-t, AUC0-infinity, Cmax, Tmax, t1/2, and lambdaz, were determined from ciprofloxacin serum concentration-time profiles for both formulations and found to be in good agreement with reported values. The parameters AUC0-t, AUC0-infinity, and Cmax 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 AUC0-t, AUC0-infinity, Cmax, 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.
Abdallah
R M
RM
Gulf Pharmaceutical Industries-Julphar, Ras Al-Khaimah, United Arab Emirates. julphard@emirates.net.ae
Alam
S M
SM
Awaad
F M
FM
Dham
R
R
El-Kersh
A
A
El-Laithy
A
A
Shalby
M H
MH
Shihabeddin
M
M
El-Walily
A F
AF
Yacout
M
M
Zaman
Q
Q
D000328:Adult; D000704:Analysis of Variance; D000890:Anti-Infective Agents / Q000097:blood*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D002939:Ciprofloxacin / Q000097:blood*; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D008297:Male; D012995:Solubility; D013607:Tablets; D013810:Therapeutic Equivalency
D000890:Anti-Infective Agents; D013607:Tablets; D002939:Ciprofloxacin