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Stendra (Avanafil) - Summary

 
 



STENDRA SUMMARY

STENDRA (avanafil) is a selective inhibitor of cGMP-specific PDE5.

STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.


See all Stendra indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Stendra (Avanafil)

Avanafil for male erectile dysfunction: a systematic review and meta-analysis. [2014]
Avanafil, a potent new selective phosphodiesterase type 5 (PDE5) inhibitor, has been developed for the treatment of erectile dysfunction (ED). We carried out a systematic review and meta-analysis to assess the efficacy and safety of this drug for the treatment of ED... Compared with avanafil 100 mg, patients who take avanafil 200 mg are more likely to experience headaches.

A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. [2013]
radical prostatectomy... CONCLUSIONS: Avanafil in 100 and 200 mg doses was effective and well tolerated in

Tolerability and pharmacokinetics of avanafil, a phosphodiesterase type 5 inhibitor: a single- and multiple-dose, double-blind, randomized, placebo-controlled, dose-escalation study in healthy Korean male volunteers. [2010]
volunteers were assessed... CONCLUSION: Avanafil was generally well tolerated and had linear pharmacokinetic

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Clinical Trials Related to Stendra (Avanafil)

Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects [Completed]
This study will assess the effect of food on the pharmacokinetics of avanafil (Formulation II); determine the relative bioavailability of two avanafil tablet formulations (Formulation I versus Formulation II) and will investigate the dose-proportionality of Formulation II avanafil tablet.

To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects. [Completed]
The objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.

Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction [Completed]
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.

To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil [Completed]
This study is being conducted to examine the effect of three CYP3A4 inhibitors (ketoconazole, erythromycin and ritonavir) on the single dose pharmacokinetics of avanafil. Ketoconazole and ritonavir are potent inhibitors of CYP3A4 and erythromycin is a moderate CYP3A4 inhibitor. Any interaction that is observed would be predictive of other inhibitors of CYP3A4.

Drug Interaction Study of Avanafil and Enalapril or Amlodipine [Completed]
The purpose of this study is to determine the change in the blood pressure and pulse rate, pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.

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Page last updated: 2015-08-10

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