Bioequivalence evaluation of two different formulations of ciprofloxacin tablets in healthy volunteers.
BACKGROUND
A bioequivalence study of two oral formulations of 500 mg tablets of ciprofloxacin (RAZA Pharmaniaga, Malaysia) as test and Ciprobay (Bayer AG, Germany) as reference, was carried out in 24 healthy human volunteers. Each volunteer received a single dose of ciprofloxacin.


METHODS
The study method used was a double-blind, two-period, two-treatment, two-sequence, and crossover randomised design. Blood samples were taken before, and within 24 hours after drug administration. Plasma concentrations of ciprofloxacin were determined by a high-performance liquid chromatographic method with ultraviolet detection. The pharmacokinetic parameters, C(max) and T(max), were obtained directly from plasma data, k(e) was estimated by log-linear regression, and the area under the curve (AUC) was calculated by the linear trapezoidal rule. The parameters, AUC(0-infinity) and C(max), were tested for bioequivalence after log-transformation of data, while the differences of T(max) were evaluated nonparametrically.


RESULTS
When AUC(0-infinity) and C(max) were analysed using analysis of variance, no statistically significant difference was observed between the two different formulations. The 90 percent confidence intervals of the mean values for the test/reference ratios were 0.95-1.07 for AUC(0-infinity) and 0.90-1.07 for C(max), respectively. Both of these values were within the bioequivalence acceptance range of 0.80-1.25.


CONCLUSIONS
We found that both formulations are bioequivalent and, therefore, interchangeable.
Hassan
Y
Y
Centre for Bioequivalence Study, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia. yahaya@usm.my
Alfadly
S O
SO
Azmin
M N
MN
Peh
K K
KK
Tan
T F Y
TF
Noorizan
A A
AA
Ismail
O
O
D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D012016:Reference Values; D013607:Tablets; D013810:Therapeutic Equivalency
D000890:Anti-Infective Agents; D013607:Tablets; D002939:Ciprofloxacin