TY - JOUR AU - Holguín, Gloria AU - Cuesta, Fanny AU - Archbold, Rosendo AU - Restrepo, Margarita AU - Parra, Sergio AU - Peña, Lina AU - Montoya, Blanca AU - Ríos, Juan Carlos AU - Toro, Victoria Eugenia AU - Ruiz, Adriana PY - 2011/04/11 Y2 - 2024/03/28 TI - Bioavalaibility and pharmacokinetic comparison of two formulations of metformin 850 mg tablets in healthy Colombian volunteers JF - Colombia Medica JA - Colomb Med VL - 42 IS - 1 SE - Original Articles DO - 10.25100/cm.v42i1.754 UR - https://colombiamedica.univalle.edu.co/index.php/comedica/article/view/754 SP - 81-87 AB - <small><span style="font-family: Arial;"><span style="font-weight: bold;">urpose:</span> The aim of this study was to compare the bioavailability of two formulations of metformin 850 mg tablets: Glucophage® from Merck Santè laboratories (reference product) and Metformin from Winthrop Pharmaceuticals de Colombia SA (test product) in healthy Colombian volunteers.</span><br style="font-family: Arial;" /> <span style="font-family: Arial;"><span style="font-weight: bold;">Methods:</span> A random, double blind, two-period, two-week wash out period, crossover study was performed in 24 healthy male and female volunteers for a single 850-mg dose of metformin tablets administrated with 240 ml of water after 12 hours of fasting. Once the drug was administrated, blood samples were collected before and within 24 hour, and plasma metformin concentration was determined by using a validated HPLC method. Pharmacokinetic parameters such as C</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;">, AUC<sub>0-96h</sub>, AUC</span></small><small><span style="font-family: Arial;"><sub>0-</sub></span></small><sub><span style="font-size: 12pt; font-family: " lang="EN-US">∞</span></sub><small><span style="font-family: Arial;">, and T</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;"> were determined. The formulations were considered bioequivalent if the logarithmic mean ratios of ln-transformed C</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;"> and AUC</span></small><small><span style="font-family: Arial;"><sub>0-</sub></span></small><sub><span style="font-size: 12pt; font-family: " lang="EN-US">∞</span></sub><small><span style="font-family: Arial;"> values were within the equivalence range of 80%-125%.</span><br style="font-family: Arial;" /> <span style="font-family: Arial;"><span style="font-weight: bold;">Results:</span> ANOVA analysis of the ln-transformed C</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;"> and AUC<sub>0-</sub></span></small><sub><span style="font-size: 12pt; font-family: " lang="EN-US">∞</span></sub><small><span style="font-family: Arial;"> indicated that none of the effects examined (formulation, period, within and between-subjet variances and carry over) was statistically significant. The mean (±SD) of C</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;"> 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC</span></small><small><span style="font-family: Arial;"><sub>0-96h</sub></span></small><small><span style="font-family: Arial;"> 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC</span></small><small><span style="font-family: Arial;"><sub>0-</sub></span></small><sub><span style="font-size: 12pt; font-family: " lang="EN-US">∞</span></sub><small><span style="font-family: Arial;">, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and T</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;"> 2.57 (± 0.93) h vs. 2.22 (± 0.94) h were obtained with test and reference formulations, respectively. These pharmacokinetic parameters presented differences with the results from other published papers. The 90% confidence interval of the logarithmic ratio of AUC</span></small><small><span style="font-family: Arial;"><sub>0-</sub></span></small><sub><span style="font-size: 12pt; font-family: " lang="EN-US">∞</span></sub><small><span style="font-family: Arial;"> and C</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;"> was within the range of 80-125%.</span><br style="font-family: Arial;" /> <span style="font-family: Arial;"><span style="font-weight: bold;">Conclusions:</span> In this study in healthy Colombian volunteers, a single 850-mg dose of metformin tablet test formulation met the criteria for bioequivalence to the reference formulation based on pharmacokinetic parameters AUC</span></small><small><span style="font-family: Arial;"><sub>0-</sub></span></small><sub><span style="font-size: 12pt; font-family: " lang="EN-US">∞</span></sub><small><span style="font-family: Arial;"> and C</span></small><small><span style="font-family: Arial;"><sub>max</sub></span></small><small><span style="font-family: Arial;">.</span></small> ER -