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Bioavalaibility and pharmacokinetic comparison of two formulations of metformin 850 mg tablets in healthy Colombian volunteers.

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Title: Bioavalaibility and pharmacokinetic comparison of two formulations of metformin 850 mg tablets in healthy Colombian volunteers.
Alternate Title: Comparación de la biodisponibilidad y la farmacocinética entre dos formulaciones de tabletas de metformina de 850 mg en voluntarios colombianos sanos.
Authors: HOLGUÍN, GLORIA1 (AUTHOR) gholguin@quimbaya.udea.edu.co, CUESTA, FANNY2 (AUTHOR) fcuesta@quimbaya.udea.edu.co, ARCHBOLD, ROSENDO3 (AUTHOR) rarchbold@farmacia.udea.edu.co, RESTREPO, MARGARITA4,5 (AUTHOR) mrestrep@farmacia.udea.edu.co, PARRA, SERGIO6 (AUTHOR) sparra@quimbaya.udea.edu.co, PEÑA, LINA7,8 (AUTHOR) lpena@medicina.udea.edu.co, MONTOYA, BLANCA9 (AUTHOR) bmontoya@medicina.udea.edu.co, RÍOS, JUAN CARLOS10 (AUTHOR) jriost@yahoo.com, TORO, VICTORIA EUGENIA11 (AUTHOR) vitopa@farmacia.udea.edu.co, RUIZ, ADRIANA12,13 (AUTHOR) geib@farmacia.udea.edu.co
Source: Colombia Medica. ene-mar2011, Vol. 42 Issue 1, p81-87. 7p. 2 Charts, 1 Graph.
Subjects: ANALYSIS of variance, BIOAVAILABILITY, CONFIDENCE intervals, CROSSOVER trials, DIABETES, HIGH performance liquid chromatography, RESEARCH funding, STATISTICAL sampling, RANDOMIZED controlled trials, METFORMIN, BLIND experiment
Geographic Terms: COLOMBIA
Abstract (English): Purpose: 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. Methods: 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 Cmax, AUC0-96h, AUC0-OO, and Tmax were determined. The formulations were considered bioequivalent if the logarithmic mean ratios of ln-transformed Cmax and AUC0-OO values were within the equivalence range of 80%-125%. Results: ANOVA analysis of the ln-transformed Cmax and AUC0-OO indicated that none of the effects examined (formulation, period, within and between-subjet variances and carry over) was statistically significant. The mean (±SD) of Cmax 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC0-96h 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC0-OO, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and Tmax 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 AUC0-OO and Cmax was within the range of 80-125%. Conclusions: 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 AUC0-OO and Cmax. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Objetivo: El objetivo de este estudio es comparar la bioequivalencia de dos formulaciones de tabletas de metformina de 850 mg: Glucophage® del Laboratorio Merck Santè (producto de referencia) y metformina de Laboratorios Winthrop Pharmaceuticals de Colombia SA (producto de prueba), en voluntarios colombianos sanos. Métodos: Se realizó un estudio aleatorizado, doble ciego, cruzado, en dos períodos y con un tiempo de lavado de dos semanas, en 24 voluntarios sanos, hombres y mujeres, que recibieron una dosis única de metformina de 850 mg, con 240 ml de agua, después de 12 horas de ayuno. Luego de la administración del medicamento, se recolectaron muestras de sangre durante 24 horas y las concentraciones plasmáticas de metformina se determinaron con un método de HPLC validado. Se calcularon los parámetros farmacocinéticos: Cmax, AUC0-96h, AUC0-OO, y Tmax. Las formulaciones se consideraron bioequivalentes si la relación de la media transformada a ln de Cmax y AUC0-OO estaba dentro del rango de bioequivalencia de 80% a 125%. Resultados: El Anova de los datos transformados a ln de Cmax y AUC0-OO indicaron que ninguno de los efectos analizados (formulación, período, variación intra e intersujetos y arrastre) fueron estadísticamente significativos. La media (±SD) de los parámetros obtenidos para los productos de prueba y de referencia, respectivamente, fueron: Cmax 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC0-96h 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC0-OO, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and Tmax 2.57 (± 0.93) h vs. 2.22 (± 0.94) h. El intervalo de confianza de la relación logarítmica del AUC0OO y Cmax se encontró dentro del rango de 80% a 125%. Conclusiones: En este estudio en voluntarios sanos colombianos, la comparación de una formulación de prueba de tabletas de metformina de 850 mg, con una formulación de referencia, cumplió los criterios de bioequivalencia teniendo como base los parámetros farmacocinéticos AUC0-OO and Cmax. [ABSTRACT FROM AUTHOR]
Copyright of Colombia Medica is the property of Universidad del Valle and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Bioavalaibility and pharmacokinetic comparison of two formulations of metformin 850 mg tablets in healthy Colombian volunteers.
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  Data: Comparación de la biodisponibilidad y la farmacocinética entre dos formulaciones de tabletas de metformina de 850 mg en voluntarios colombianos sanos.
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  Data: <searchLink fieldCode="AR" term="%22HOLGUÍN%2C+GLORIA%22">HOLGUÍN, GLORIA</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> gholguin@quimbaya.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22CUESTA%2C+FANNY%22">CUESTA, FANNY</searchLink><relatesTo>2</relatesTo> (AUTHOR)<i> fcuesta@quimbaya.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22ARCHBOLD%2C+ROSENDO%22">ARCHBOLD, ROSENDO</searchLink><relatesTo>3</relatesTo> (AUTHOR)<i> rarchbold@farmacia.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22RESTREPO%2C+MARGARITA%22">RESTREPO, MARGARITA</searchLink><relatesTo>4,5</relatesTo> (AUTHOR)<i> mrestrep@farmacia.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22PARRA%2C+SERGIO%22">PARRA, SERGIO</searchLink><relatesTo>6</relatesTo> (AUTHOR)<i> sparra@quimbaya.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22PEÑA%2C+LINA%22">PEÑA, LINA</searchLink><relatesTo>7,8</relatesTo> (AUTHOR)<i> lpena@medicina.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22MONTOYA%2C+BLANCA%22">MONTOYA, BLANCA</searchLink><relatesTo>9</relatesTo> (AUTHOR)<i> bmontoya@medicina.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22RÍOS%2C+JUAN+CARLOS%22">RÍOS, JUAN CARLOS</searchLink><relatesTo>10</relatesTo> (AUTHOR)<i> jriost@yahoo.com</i><br /><searchLink fieldCode="AR" term="%22TORO%2C+VICTORIA+EUGENIA%22">TORO, VICTORIA EUGENIA</searchLink><relatesTo>11</relatesTo> (AUTHOR)<i> vitopa@farmacia.udea.edu.co</i><br /><searchLink fieldCode="AR" term="%22RUIZ%2C+ADRIANA%22">RUIZ, ADRIANA</searchLink><relatesTo>12,13</relatesTo> (AUTHOR)<i> geib@farmacia.udea.edu.co</i>
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  Data: <searchLink fieldCode="JN" term="%22Colombia+Medica%22">Colombia Medica</searchLink>. ene-mar2011, Vol. 42 Issue 1, p81-87. 7p. 2 Charts, 1 Graph.
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  Data: Purpose: 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. Methods: 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 Cmax, AUC0-96h, AUC0-OO, and Tmax were determined. The formulations were considered bioequivalent if the logarithmic mean ratios of ln-transformed Cmax and AUC0-OO values were within the equivalence range of 80%-125%. Results: ANOVA analysis of the ln-transformed Cmax and AUC0-OO indicated that none of the effects examined (formulation, period, within and between-subjet variances and carry over) was statistically significant. The mean (±SD) of Cmax 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC0-96h 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC0-OO, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and Tmax 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 AUC0-OO and Cmax was within the range of 80-125%. Conclusions: 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 AUC0-OO and Cmax. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: Objetivo: El objetivo de este estudio es comparar la bioequivalencia de dos formulaciones de tabletas de metformina de 850 mg: Glucophage® del Laboratorio Merck Santè (producto de referencia) y metformina de Laboratorios Winthrop Pharmaceuticals de Colombia SA (producto de prueba), en voluntarios colombianos sanos. Métodos: Se realizó un estudio aleatorizado, doble ciego, cruzado, en dos períodos y con un tiempo de lavado de dos semanas, en 24 voluntarios sanos, hombres y mujeres, que recibieron una dosis única de metformina de 850 mg, con 240 ml de agua, después de 12 horas de ayuno. Luego de la administración del medicamento, se recolectaron muestras de sangre durante 24 horas y las concentraciones plasmáticas de metformina se determinaron con un método de HPLC validado. Se calcularon los parámetros farmacocinéticos: Cmax, AUC0-96h, AUC0-OO, y Tmax. Las formulaciones se consideraron bioequivalentes si la relación de la media transformada a ln de Cmax y AUC0-OO estaba dentro del rango de bioequivalencia de 80% a 125%. Resultados: El Anova de los datos transformados a ln de Cmax y AUC0-OO indicaron que ninguno de los efectos analizados (formulación, período, variación intra e intersujetos y arrastre) fueron estadísticamente significativos. La media (±SD) de los parámetros obtenidos para los productos de prueba y de referencia, respectivamente, fueron: Cmax 1217.38 (± 251.72) ng/ml vs. 1305.25 (± 301.06) ng/ml, AUC0-96h 1363.49 (± 315.51) ng.h/ml vs. 1584.82 (± 368.75) ng.h/ml, AUC0-OO, 7155.75 (± 1440.74) ng.h/ml vs. 7777.08 (± 1896.49) ng.h/ml, and Tmax 2.57 (± 0.93) h vs. 2.22 (± 0.94) h. El intervalo de confianza de la relación logarítmica del AUC0OO y Cmax se encontró dentro del rango de 80% a 125%. Conclusiones: En este estudio en voluntarios sanos colombianos, la comparación de una formulación de prueba de tabletas de metformina de 850 mg, con una formulación de referencia, cumplió los criterios de bioequivalencia teniendo como base los parámetros farmacocinéticos AUC0-OO and Cmax. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Colombia Medica is the property of Universidad del Valle and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=lth&AN=61213271
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      – Code: eng
        Text: English
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        PageCount: 7
        StartPage: 81
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      – SubjectFull: ANALYSIS of variance
        Type: general
      – SubjectFull: BIOAVAILABILITY
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      – SubjectFull: CONFIDENCE intervals
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      – SubjectFull: CROSSOVER trials
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      – SubjectFull: DIABETES
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      – SubjectFull: RANDOMIZED controlled trials
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      – SubjectFull: METFORMIN
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      – SubjectFull: BLIND experiment
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      – SubjectFull: COLOMBIA
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