To study the effect of oral edenafil citrate tablets on the antihypertensive effect of nifedipine controlled-release tablets in Chinese male hypertensive subjects and the safety of their combined use.

Start Date20 Jul 2023

Sponsor / Collaborator

Tianjin Institute of Pharmaceutical Research Co., Ltd.

[+1]

CTR20232103 / CompletedPhase 4

枸橼酸爱地那非片连续多次给药的药代动力学的单中心研究

[Translation] A single-center study on the pharmacokinetics of edenafil citrate tablets after multiple consecutive doses

研究中国健康受试者多次口服30mg枸橼酸爱地那非片的药代动力学特征及耐受性和安全性。

[Translation]

To study the pharmacokinetic characteristics, tolerability and safety of multiple oral administration of 30 mg edenafil citrate tablets in healthy Chinese subjects.

Start Date11 Apr 2023

Sponsor / Collaborator

Tianjin Institute of Pharmaceutical Research Co., Ltd.

[+1]

CTR20232100 / CompletedPhase 4

枸橼酸爱地那非片与克拉霉素、利福平、西咪替丁相互作用的药代动力学的单中心研究

[Translation] A single-center study on the pharmacokinetic interaction between eldenafil citrate tablets and clarithromycin, rifampicin, and cimetidine

研究中国健康男性受试者口服克拉霉素后，对枸橼酸爱地那非片药代动力学特征的影响及两者合并使用的安全性。研究中国健康男性受试者口服利福平后，对枸橼酸爱地那非片药代动力学特征的影响及两者合并使用的安全性。研究中国健康男性受试者口服西咪替丁后，对枸橼酸爱地那非片药代动力学特征的影响及两者合并使用的安全性。

[Translation]

To study the effect of oral clarithromycin on the pharmacokinetic characteristics of ardenafil citrate tablets in healthy Chinese male subjects and the safety of their combined use. To study the effect of oral rifampicin on the pharmacokinetic characteristics of ardenafil citrate tablets in healthy Chinese male subjects and the safety of their combined use. To study the effect of oral cimetidine on the pharmacokinetic characteristics of ardenafil citrate tablets in healthy Chinese male subjects and the safety of their combined use.

Start Date06 Mar 2023

Sponsor / Collaborator

Tianjin Institute of Pharmaceutical Research Co., Ltd.

[+1]

100 Clinical Results associated with Aildenafil Citrate

100 Translational Medicine associated with Aildenafil Citrate

100 Patents (Medical) associated with Aildenafil Citrate

Literatures (Medical) associated with Aildenafil Citrate

01 Feb 2024·Sexual Medicine

Safety, tolerability, and pharmacokinetics of aildenafil citrate tablets, a novel oral PDE5 inhibitor, in healthy Chinese volunteers after multiple-dose administration

Article

Author: Zhao, Xia ; Cui, Yimin ; Zhao, Nan ; Wang, Xia ; Jia, Bo ; Cheng, Lu ; He, Xu ; Xie, Ran

AbstractBackgroundAildenafil citrate is a potent and selective inhibitor of cyclic guanosine monophosphate–specific phosphodiesterase type 5, developed for the treatment of erectile dysfunction (ED).AimThis study aimed to assess the pharmacokinetics, safety, and tolerability of aildenafil citrate tablets after multiple doses in healthy Chinese males.MethodsTwenty participants were divided into 2 groups, 10 participants each. Participants were administered multiple doses of aildenafil citrate tablets at 30 and 60 mg.OutcomesThe safety evaluation was based on clinical symptoms and adverse events. Concentrations of aildenafil and its key metabolites (M1, M5, and M12) in human serum were measured by liquid chromatography–tandem mass spectrometry.ResultsPharmacokinetic analysis showed rapid absorption and elimination of aildenafil, with a median time to maximum serum concentration of 1 hour and mean terminal half-lives of 2.75 and 3.26 hours in the respective dose groups. The mean maximum concentration was proportional to the aildenafil dose in the range of 30 to 60 mg, although the area under the curve was not proportional for serum concentration vs time 0 to the last measurable time point (24 hours). Multiple doses of aildenafil were well tolerated, with 60.0% of men experiencing treatment-emergent adverse events, notably myalgia and fatigue, particularly in the 60-mg group.Clinical ImplicationsAildenafil citrate tablets demonstrated favorable tolerability with once-daily administration over the clinical dose range. The occurrence of myalgia and fatigue was more prevalent in the 60-mg group. From a pharmacokinetic perspective, optimal administration of aildenafil citrate tablets appears to be 1 hour before sexual intercourse in men with ED.Strengths and LimitationsThis study presents robust safety and pharmacokinetic data at expected therapeutic doses, unaffected by clinical factors. The efficacy of aildenafil citrate tablets warrants further validation in individuals with ED.ConclusionAildenafil citrate tablets exhibited good tolerability in healthy Chinese males following multiple doses at 30 and 60 mg. The 60-mg group showed an increased incidence of myalgia and fatigue, suggesting the need for heightened clinical vigilance. The mean maximum concentration, but not the area under the curve, displayed dose proportionality within the 30- to 60-mg dose range, and no significant drug accumulation was observed with repeated daily administration.Clinical Trial RegistrationCTR20192473 (http://www.chinadrugtrials.org.cn).

01 Aug 2021·Translational Andrology and UrologyQ4 · MEDICINE

Efficacy and safety of aildenafil citrate in Chinese men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled crossover trial

Q4 · MEDICINE

Article

Author: Lei, Hong-En ; Cui, Wan-Shou ; Guan, Rui-Li ; Feng, Yu-Hong ; Zhu, Sai-Nan ; Wang, Jiang ; Yao, Chen ; Xin, Zhong-Cheng ; Tian, Long ; Wang, Tao ; Liu, Ji-Hong

BACKGROUNDTo evaluate the efficacy and safety of aildenafil citrate in the treatment of erectile dysfunction (ED) in Chinese population.METHODSA multicenter, randomized, double-blind, placebo-controlled, double-cycle crossover trial was conducted in three medical centers. Male patients with mild to moderate ED were randomized into two groups and received either aildenafil citrate or placebos, followed by a crossover administration after a 7-day washout. The primary outcome was the duration of penile rigidity over 60% measured by RigiScan^® Plus. Main secondary outcomes were the duration of penile rigidity over 80% and erectile hardness score (EHS).RESULTSA total of 60 patients with mild to moderate ED were enrolled in the study and 57 of them completed the trial (30 in the aildenafil group and 27 in the placebo group). The median duration of penile tip rigidity over 60% was 4.25 (0.00, 19.00) min in the aildenafil group, as compared with 0.50 (0.00, 2.75) min in the placebo group (P<0.001). The median duration of penile base rigidity over 60% was 3.25 (0.00, 12.50) min in the aildenafil group, as compared with 0.00 (0.00, 2.50) min in the placebo group (P<0.001). The duration of penile base rigidity over 80% was significantly increased in the aildenafil group versus the placebo group (P=0.002). The EHS was significantly improved in the aildenafil group (P<0.001). No severe adverse events associated with aildenafil citrate occurred in both groups.CONCLUSIONSThese results suggested that aildenafil citrate was efficient and well-tolerated in the treatment of Chinese men with mild to moderate ED.TRIAL REGISTRATIONChinese Clinical Trial Registry ChiCTR1900026025.

01 Jul 2018·Journal of Food and Drug AnalysisQ2 · MEDICINE

Simultaneous analysis of 23 illegal adulterated aphrodisiac chemical ingredients in health foods and Chinese traditional patent medicines by ultrahigh performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry

Q2 · MEDICINE

ArticleOA

Author: Xu, Li-Hua ; Liu, Bing-Jie ; Yu, Hai-Ying ; Xian, Rui-Qing ; Sun, Yang-En ; Wang, Xiao-Bing ; Li, Jun-Jie ; Zheng, Jing ; Li, Qi-Yan ; Liu, Ming-Jie

This paper presents an application of ultra high-performance liquid-chromatography-quadrupole-TOF high resolution mass spectrometry (UHPLC-Q-TOF HRMS) for simultaneous analysis of 23 illegal adulterated aphrodisiac type chemical ingredients in health foods and Chinese Traditional Patent Medicines (CTPMs). The mass spectrometer was operated in Information Dependent Acquisition (IDA) mode, which provides crucial information for the elemental composition analysis, structure elucidation and quantitative analysis simultaneously. Quantitative analysis was performed using the peak areas of the precursor ions in the XICs. The method validation included assessment of selectivity, sensitivity, calibration curve, accuracy, precision, recovery, matrix effect and stability. The results show good linear relationship with the concentrations of the analytes over wide concentration ranges (e.g., 0.05-10 μg/g for sildenafil) as all the fitting coefficients of determination r² are >0.9984. The detection limits (LODs) were in the range of 0.002-0.1 μg/g. The recoveries were able to reach 82.5-103.6%, while the matrix effects ranged from 87.7 to 109.3%. The intra- and inter-day accuracies were in the range of 82.3-113.8%, while the intra- and inter-day precision ranged from 0.4 to 13.6%. Among 40 batches of health foods and 32 batches of CTPMs (including 28 capsules, 32 tablets, 10 liquid and 2 pills) samples, 28 batches of heath foods were positive. The detected chemical ingredients involved sildenafil, tadalafil, aildenafil and sulfoaildenafil. This method can be used for the screening, identification and quantification of illegal adulterated aphrodisiac chemical ingredients in health foods and CTPMs. Moreover, the LC-Q-TOF MS is very useful to structural elucidation of unknown compound.

100 Deals associated with Aildenafil Citrate

External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Erectile Dysfunction	CN	Yuekang Pharmaceutical Group Co., Ltd.	27 Dec 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Erectile Dysfunction	Phase 1	CN	Beijing Wannianchun Biological Medicine High Technology Co., Ltd.	10 Jul 2017
Erectile Dysfunction	Phase 1	CN	Tianjin Institute of Pharmaceutical Research Co., Ltd.	10 Jul 2017

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