다이비스 정(염산메트폴민 500 mg)의 생물학적 동등성

• 영문명: Bioequivalence of Dybis Tablet (Metformin Hydrochloride 500 mg)
• 발행기관: 대한약학회
• 저자명: 최준식(Jun Sik Choi) 박영진(Young Jin Park) 박상묵(Sang Muk Park) 범진필(Jin Pil Burm)
• 간행물 정보: 『약학회지』제47권 제4호 (2003년), 239~243쪽, 전체 5쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2003.08.30

영문 초록

Metformin is an oral antihyperglycemic agent used in the therapy of noninsulin- dependent diabetes mellitus and does not cause hypoglycemia at the therapeutic dose. The purpose of the present study was to evaluate the bioequivalence of two metformin hydrochloride tablets, Glucophage tablet (Daewoong Pharmaceutical Co., reference drug) and Dybis tablet (Shinpoong Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration(KFDA). Twenty-four normal volunteers, 26.6±4.01 years in age and 60.6±9.80 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 500 mg of metformin hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of metformin hydrochloride in serum were determined using HPLC with UV detector The pharmacokinetic parameters such as AUCt, Cmak and Tmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUCt, Cmax and Tmax between two products were -1.05%, -6.76% and -4.51%, respectively, when calculated against the reference drug. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8≤δ≤log1.25 (e.g., log0.9082≤δ≤log1.0906 and log0.8188 ≤δ≤log1.0392 for AUCt and Cmax, respectively). The 90% confidence intervals using untransformed data was within ±20% (e.g., -17.66%≤δ≤ 8.63% for Tmax). All parameters met the criteria of KFDA for bioequivalence, indicating that Dybis tablets (Shinpoong Pharmaceutical Co.) is bioequivalent to Glucophage tablets (DaeWoong Pharmaceutical Co.).

키워드

bioequivalence dybis tablet metformin hydrochloride tablet cross-over study.