Estudio comparativo, cruzado, al azar, para la determinación de la bioequivalencia entre dos formulaciones de oxcarbazepina en tabletas

Gloria Shirley Ramírez Correa; Piedad Restrepo Valencia; Milena Pérez Guzmán; Mauricio Pérez Flórez; Eduar Echeverri García

Estudio comparativo, cruzado, al azar, para la determinación de la bioequivalencia entre dos formulaciones de oxcarbazepina en tabletas

Translated title of the contribution: Bioequivalence comparison of two formulations of oxcarbazepine tablets: A two period, single dose, randomized, cross-over study

Gloria Shirley Ramírez Correa, Piedad Restrepo Valencia, Milena Pérez Guzmán, Mauricio Pérez Flórez, Eduar Echeverri García

International Center for Medical Research and Training (CIDEIM)

Research output: Contribution to journal › Article › peer-review

Abstract

Two formulations of oxcarbazepine (Trileptal®, Novartis, y Oxcarbazepina®, Tecnoquímicas S. A.), previously shown to be pharmaceutical equivalents, were evaluated concerning their bioequivalence by means of a randomized, crossover, single oral dose (1.200 mg), two-period study in 24 healthy adult males. The following pharmacokinetic parameters were determined: Area under the curve (AUC), Maximal concentration (C_max), and Time to reach maximal concentration (T_max). There was a wash-out interval of seven days between the two periods. Plasmatic concentrations of the drug were measured with HPLC/UV with standard addition. No significant differences were found between the two preparations. It was concluded that they are pharmaceutical equivalents as well as bioequivalent. Consequently, they are interchangeable for therapeutic purposes.

Translated title of the contribution	Bioequivalence comparison of two formulations of oxcarbazepine tablets: A two period, single dose, randomized, cross-over study
Original language	Spanish
Pages (from-to)	205-212
Number of pages	8
Journal	Iatreia
Volume	22
Issue number	3
State	Published - Sep 2009
Externally published	Yes

Cite this

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title = "Estudio comparativo, cruzado, al azar, para la determinaci{\'o}n de la bioequivalencia entre dos formulaciones de oxcarbazepina en tabletas",

abstract = "Two formulations of oxcarbazepine (Trileptal{\textregistered}, Novartis, y Oxcarbazepina{\textregistered}, Tecnoqu{\'i}micas S. A.), previously shown to be pharmaceutical equivalents, were evaluated concerning their bioequivalence by means of a randomized, crossover, single oral dose (1.200 mg), two-period study in 24 healthy adult males. The following pharmacokinetic parameters were determined: Area under the curve (AUC), Maximal concentration (Cmax), and Time to reach maximal concentration (Tmax). There was a wash-out interval of seven days between the two periods. Plasmatic concentrations of the drug were measured with HPLC/UV with standard addition. No significant differences were found between the two preparations. It was concluded that they are pharmaceutical equivalents as well as bioequivalent. Consequently, they are interchangeable for therapeutic purposes.",

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AU - Correa, Gloria Shirley Ramírez

AU - Valencia, Piedad Restrepo

AU - Guzmán, Milena Pérez

AU - Flórez, Mauricio Pérez

AU - García, Eduar Echeverri

PY - 2009/9

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N2 - Two formulations of oxcarbazepine (Trileptal®, Novartis, y Oxcarbazepina®, Tecnoquímicas S. A.), previously shown to be pharmaceutical equivalents, were evaluated concerning their bioequivalence by means of a randomized, crossover, single oral dose (1.200 mg), two-period study in 24 healthy adult males. The following pharmacokinetic parameters were determined: Area under the curve (AUC), Maximal concentration (Cmax), and Time to reach maximal concentration (Tmax). There was a wash-out interval of seven days between the two periods. Plasmatic concentrations of the drug were measured with HPLC/UV with standard addition. No significant differences were found between the two preparations. It was concluded that they are pharmaceutical equivalents as well as bioequivalent. Consequently, they are interchangeable for therapeutic purposes.

AB - Two formulations of oxcarbazepine (Trileptal®, Novartis, y Oxcarbazepina®, Tecnoquímicas S. A.), previously shown to be pharmaceutical equivalents, were evaluated concerning their bioequivalence by means of a randomized, crossover, single oral dose (1.200 mg), two-period study in 24 healthy adult males. The following pharmacokinetic parameters were determined: Area under the curve (AUC), Maximal concentration (Cmax), and Time to reach maximal concentration (Tmax). There was a wash-out interval of seven days between the two periods. Plasmatic concentrations of the drug were measured with HPLC/UV with standard addition. No significant differences were found between the two preparations. It was concluded that they are pharmaceutical equivalents as well as bioequivalent. Consequently, they are interchangeable for therapeutic purposes.

KW - Bioequivalence

KW - Oxcarbazepine tablets

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SN - 0121-0793

VL - 22

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JO - Iatreia

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ER -

Estudio comparativo, cruzado, al azar, para la determinación de la bioequivalencia entre dos formulaciones de oxcarbazepina en tabletas

Abstract

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