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Be Part of Research - Trial Details - Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products
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Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products

Completed

Open to: MALE

Age: 18.0 - 65.0

Glasgow

Medical Conditions

Erectile Dysfunction

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The study will assess a new biphasic release sildenafil formulation (N4S001), developed by N4 Pharma. The N4S001 tablet contains a total of 100 mg sildenafil.

The N4S001 tablet is designed to provide a faster onset of release and a longer therapeutic window compared to currently marketed sildenafil products.

This is a single centre, open-label, four-arm crossover study in up to 12 healthy male volunteers.

The following treatments will be dosed:

Assessment Visit 1: N4S001 tablet containing 100 mg sildenafil (fasted)

Assessment Visit 2: N4S001 tablet containing 100 mg sildenafil (fed)

Assessment Visit 3: Viagra film-coated tablet containing 50 mg sildenafil (fasted)

Assessment Visit 4: Viagra film-coated tablet containing 50 mg sildenafil (fed)

The immediate release layer of each N4S001 tablet will be radiolabelled to contain 4 MBq (megabecquerel) 99mTc at time of dose.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2018 Jun 2018

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 100 mg biphasic sildenafil tablet

Intervention Arm Group : Sublingual sildenafil (fasted);Sublingual sildenafil (fed);

Intervention Type : DRUG
Intervention Description : 50 mg oral sildenafil (Viagra)

Intervention Arm Group : Oral comparator (fasted);Oral sildenafil (fed);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • BDD Pharma Ltd
    Glasgow
    G4 0SF


The study is sponsored by N4 Pharma UK Ltd. and is in collaboration with BDD Pharma Ltd.



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Read full details for Trial ID: NCT03510338
Last updated 09 July 2018

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