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A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer

NCT02850718 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-08-19

No results posted yet for this study

Summary

A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test sublingual sildenafil wafer.

Conditions

Interventions

DRUG

Sublingual Sildenafil

50 mg sildenafil sublingual wafer.

DRUG

Oral Sildenafil

50 mg oral sildenafil (Viagra)

Sponsors & Collaborators

  • Linear Clinical Research

    collaborator INDUSTRY

  • iX Biopharma Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Australia

Study Locations

More Related Trials

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 NCT02850718 on ClinicalTrials.gov