Oral Pharmacokinetics of Mirodenafil in Mexican Healthy Volunteers
Miriam del Carmen Carrasco-Portugal, Francisco Javier Flores-Murrieta, Juan Gerardo Reyes-García, Noemí Santos-Caballero
Landsteiner Scientific, S.A. de C.V., México DF, México.
Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, México DF, México.
Unidad de Investigación en Farmacología, Insituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas”, México DF, México.
Unidad de Investigación en Farmacología, Insituto Nacional de Enfermedades Respiratorias “Ismael Cosio Villegas”, México DF, México; Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, México DF, México.
DOI: 10.4236/pp.2014.51016   PDF   HTML     5,066 Downloads   7,027 Views   Citations


Mirodenafil is a 5-phosphodiesterase inhibitor that is currently marketed in Korea for the treatment of erectile dysfunction; however, no information in other populations is available. It has been described that Mirodenafil is metabolized by CYP3A4, a metabolic pathway in which interethnic differences have been reported. The purpose of this study was to characterize the oral pharmacokinetics of Mirodenafil in Mexicans. Seventeen male healthy volunteers were enrolled in this study. After an overnight fast, volunteers received an oral 100 mg dose and blood samples were collected at selected times during 24 h. Plasma was stored frozen and analyzed by an HPLC method. Pharmacokinetic parameters obtained were: Cmax 331.129 ± 32.689 ng/mL, tmax 1.574 ± 0.293 h, AUC24h 883.293 ± 104.088 ng·h/mL, AUC 976.477 ± 108.812 ng·h/mL and t1/2 1.807 ± 0.171 h. Parameter values observed in this study are similar to those reported in Koreans. Since efficacy and safety studies of Mirodenafil have been conducted in Koreans, it is expected that dosage regime to employ in Mexicans should be similar to the approved for Korean population.

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M. Carrasco-Portugal, F. Flores-Murrieta, J. Reyes-García and N. Santos-Caballero, "Oral Pharmacokinetics of Mirodenafil in Mexican Healthy Volunteers," Pharmacology & Pharmacy, Vol. 5 No. 1, 2014, pp. 112-116. doi: 10.4236/pp.2014.51016.

Conflicts of Interest

The authors declare no conflicts of interest.


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