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 Original Articles |
| Comparison of Bioequivalence of Two Cefixime Capsule Preparations after oral Administration |
| Chin-Yang Kang1, Seong-Hoon Seo2, Kyung-Tae Lee3, Chang-Hoon Moon3, Jin-Han Kang4, Dong-Gun Lee5, Jung-Hyun Choi5, Wan-Shik Shin5 |
| College of Pharmacy, Sahm Yook University1, College of Pharmacy, Kyung-Hee University2, Department of Internal Medicine, Seoul Adventist Hospital3, Department of Pediatrics4, Department of Internal Medicine5 College of Medicine, The Catholic University of Korea |
Vol.18 Num.4 (p379~389)
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Background : The study was designed to compare the bioeqivalence between the test (CEXIME, United Korea. Co., Ltd) and control (SUPRAX, Dong-a Pharm. Co., Ltd) capsules of cefixime.
Methods : Twenty, healthy, male volunteers completed the study. Each subject ingested single dose (100 mg) of the control and test drugs in 2×2 crossover design with a week drug-free interval between the doses. Blood samples were collected serially up to 12 hours and plasma concentrations of cefixime were measured by highperformance liquid chromatography with UV detection. A non-compartmental approach was used for analysis of the concentration-time data.
Results : The area under the curve (AUC), the maximum concentration of drug (Cmax), and time to reach Cmax (Tmax) did not show any significant difference between the two preparations by ANOVA. The mean differences of AUC, Cmax, and Tmax were within 20% of the control drug, those were 1.26%, 3.73%, and 6.21%, respectively. The confidence limits of three parameters were satisfied the bioeqivalence criteria.
Conclusion : These results suggest that the test drug was bioequivalent with the control drug.
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Keywords : Cefixime, Bioequivalance, Pharmacokinetics |
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