Pharmacokinetic profile of sildenafil citrate in healthy Middle Eastern Males: Comparison with other ethnicities

Autor:	Hisham S. Abou-Auda, Ziyad Alrabiah, Abdulrahman Alwhaibi, Badraddin M.H. Al-Hadiya, Sary Alsanea, Fars K. Alanazi
Jazyk:	angličtina
Rok vydání:	2021
Předmět:	Pharmacology Sildenafil business.industry Significant difference Cmax Pharmaceutical Science Physiology RM1-950 Bioequivalence chemistry.chemical_compound Pharmacokinetics chemistry Ethnicity Medicine Original Article Therapeutics. Pharmacology business Adverse effect Middle Eastern
Zdroj:	Saudi Pharmaceutical Journal, Vol 29, Iss 12, Pp 1498-1505 (2021) Saudi Pharmaceutical Journal : SPJ
ISSN:	1319-0164
Popis:	Aim 1) To investigate the pharmacokinetic profile of sildenafil citrate in Middle Eastern males and, 2) To highlight the impact of ethnicity on its pharmacokinetics parameters through comparing Middle Eastern data to the data estimated from different ethnic groups. Method The study was conducted on 24 Middle Eastern healthy male volunteers. Pharmacokinetic data including Cmax, Tmax, t1/2, AUC0-t, AUC0-∞ were estimated from blood samples collected at several time points within 24 hours post-administration of a single 100-mg tablet of sildenafil citrate (Viagra®). Pharmacokinetic data of sildenafil generic 100-mg tablet (product B) was determined in the volunteers using the same analytical method. Pharmacokinetic data of other studies published on different ethnicities were obtained and compared to our Viagra®-related data. Results Analysis of Middle Eastern data (mean ± SD) revealed Cmax = 398.9 ± 107.7 ng/ml; Tmax = 1.84 ± 0.22 hours; t1/2 = 2.66 ± 0.97 h; AUC0–24 = 1475 ± 515.3 ng.h/ml; AUC0-∞ = 1556 ± 567.58 ng.h/ml. There was no significant difference between Viagra® and product B, confirming the bioequivalence of the two preparation as well as the reliability of utilized analytical method. Data comparisons between Middle Eastern and other ethnicities indicated that Iranian, Mexican, and Thai would potentially have twice the effect observed in Arabs and Caucasians, considering the same prescribed drug formulation and dose. Conclusion There is a considerable difference in the pharmacokinetic profile of sildenafil citrate between Middle Eastern and other ethnic groups. Ethnicity may predispose individuals to unwanted prolonged activity of sildenafil and adverse events. Thus, it should be taken in consideration by clinicians when recommending sildenafil dose.
Databáze:	OpenAIRE
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