BIOEQUIVALENCE COMPARISON OF TWO FORMULATIONS OF FIXED-DOSE COMBINATION GLIMEPIRIDE/METFORMIN (2/500 MG)TABLETS IN HEALTHY VOLUNTEERS

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JUNG SANG HOON; CHAE JUNG WOO; SONG BYUNG JEONG; KWONA KWANG IL

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Journal: Iranian Journal of Pharmaceutical Research Year:2014 | Volume:13 | Issue:2 Page(s): 365-371

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Title

BIOEQUIVALENCE COMPARISON OF TWO FORMULATIONS OF FIXED-DOSE COMBINATION GLIMEPIRIDE/METFORMIN (2/500 MG)TABLETS IN HEALTHY VOLUNTEERS

Author(s)

JUNG SANG HOON | CHAE JUNG WOO | SONG BYUNG JEONG | KWONA KWANG IL | Issue Writer Certificate

Keywords

METFORMIN

GLIMEPIRIDE

COMBINATION DRUG

BIOEQUIVALENCE

PHARMACOKINETIC PROPERTIES

Abstract

Glimepiride/METFORMIN (2.500 mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic GLIMEPIRIDE/METFORMIN (2.500 mg) fixed-dose combination (FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers. This single-dose, randomized, double-blind, two-way crossover trial was conducted at Bestian Medical Center in Bucheon, Korea. In total, 40 male Korean volunteers were enrolled. The subjects were randomized to receive an FDC tablet containing the GLIMEPIRIDE/METFORMIN (2.500 mg) test or reference formulation, and pharmacokinetic (PK) parameters were measured. After a 1-week washout period, the other formulation was administered and the PK parameters were measured again. The Cmax and AUCt were determined from blood samples obtained at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 h after drug administration. BIOEQUIVALENCE was considered established if the 90% CIs of the geometric mean ratios (GMRs) of the test-to-reference formulations for Cmax and AUCt were within the predetermined regulatory range of 80-125%. Intotal, 40 healthy male subjects were enrolled and completed the study (mean [SD] age, 23.2 [2.26] years [range, 19-30years]; weight, 68.95 [8.30] Kg [range, 52.0-87.0 Kg]; and height, 175.4 [5.34] cm [range, 164-189 cm]). The GMRs (90% CI) of the GLIMEPIRIDE Cmax and AUCt were 1.006 (0.947-1.069) and 1.010 (0.953-1.071), respectively. For METFORMIN, the values were 1.019 (0.959-1.083) and 1.035 (0.989-1.084), respectively. The test and reference formulations had similar PK parameters. The test formulation of GLIMEPIRIDE/METFORMIN (2.500 mg) FDC tablets met the Korean regulatory criteria for BIOEQUIVALENCE.

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APA: Copy

JUNG, SANG HOON, CHAE, JUNG WOO, SONG, BYUNG JEONG, & KWONA, KWANG IL. (2014). BIOEQUIVALENCE COMPARISON OF TWO FORMULATIONS OF FIXED-DOSE COMBINATION GLIMEPIRIDE/METFORMIN (2/500 MG)TABLETS IN HEALTHY VOLUNTEERS. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 13(2), 365-371. SID. https://sid.ir/paper/288232/en

Vancouver: Copy

JUNG SANG HOON, CHAE JUNG WOO, SONG BYUNG JEONG, KWONA KWANG IL. BIOEQUIVALENCE COMPARISON OF TWO FORMULATIONS OF FIXED-DOSE COMBINATION GLIMEPIRIDE/METFORMIN (2/500 MG)TABLETS IN HEALTHY VOLUNTEERS. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2014;13(2):365-371. Available from: https://sid.ir/paper/288232/en

IEEE: Copy

SANG HOON JUNG, JUNG WOO CHAE, BYUNG JEONG SONG, and KWANG IL KWONA, “BIOEQUIVALENCE COMPARISON OF TWO FORMULATIONS OF FIXED-DOSE COMBINATION GLIMEPIRIDE/METFORMIN (2/500 MG)TABLETS IN HEALTHY VOLUNTEERS,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 13, no. 2, pp. 365–371, 2014, [Online]. Available: https://sid.ir/paper/288232/en

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