Oral Pharmacokinetics of Mirodenafil in Mexican Healthy Volunteers

• 作者: Francisco Javier Flores-Murrieta Juan Gerardo Reyes-García Miriam del Carmen Carrasco-Portugal Noemí Santos-Caballero
• 来源期刊: 药理与制药(英文)
• 学科: 医学
• 关键词: Erectile DYSFUNCTION HEALTHY VOLUNTEERS MEXICAN Mirodenafil PHARMACOKINETIC
• 年，卷（期）: 2014,（1）
• 页码范围: 112-116
• 页数: 5页
• 分类号: R73

摘要

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.