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Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products

NCT03510338 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-07-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sublingual sildenafil

100 mg biphasic sildenafil tablet

DRUG

Oral sildenafil

50 mg oral sildenafil (Viagra)

Sponsors & Collaborators

  • BDD Pharma Ltd

    collaborator INDUSTRY

  • N4 Pharma UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Howard NE Stevens, FRPharmS · BDD Pharma Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2018-06-13
Completion
2018-06-13

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510338 on ClinicalTrials.gov