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

NCT02850718 | Completed Phase 3

• 1 other identifier: SIL-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Sildenafil plasma concentrations

  1 week

Secondary Outcomes (1)

• Number of patients with treatment-related adverse events

  1 week

Study Arms (2)

Period 1: Sublingual wafer

EXPERIMENTAL

Subjects receive receive a single dose of 50 mg sublingual sildenafil followed by plasma sampling for 14 hours.

Drug: Sublingual Sildenafil

Period 2: Oral comparator

ACTIVE COMPARATOR

Subjects receive a single dose of 50 mg oral sildenafil (Viagra) followed by plasma sampling for 14 hours.

Drug: Oral Sildenafil

Interventions

Sublingual Sildenafil DRUG

50 mg sildenafil sublingual wafer.

Also known as: Pheonix

Period 1: Sublingual wafer

Oral Sildenafil DRUG

50 mg oral sildenafil (Viagra)

Also known as: Viagra

Period 2: Oral comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily provides signed, written, and dated informed consent prior to any study-specific procedures.
• Healthy male volunteers aged 18-50 years inclusive.
• In good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the Principal Investigator.
• Sufficient access for venous cannulation to withdraw blood as per the study design.
• Body mass index (BMI) of ≥19 to ≤ 30kg/m2 (inclusive).
• Participant is deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.
• Able to refrain from smoking while at the research unit.

You may not qualify if:

• Past history of hypersensitivity to sildenafil, any of its excipients, or severe allergic or anaphylactic reaction to any other drug.
• A medical condition that, in the opinion of the Investigator, may adversely impact the participant's ability to complete the study, including but not limited to:
• History of priapism;
• History of easy fainting or symptomatic postural hypotension;
• Standing or supine systolic blood pressure \< 90mmHg or diastolic blood pressure \< 50mm Hg or postural drop of \>30mm Hg;
• History of myocardial infarction or clinically significant cardiac disease including cardiac arrhythmia;
• History of retinitis pigmentosa or optic neuropathy or other risk factors of non-arteritic anterior ischaemic optic neuropathy (NAION);
• History or evidence of hypertension - defined as three BP readings (at rest) within 15 minutes of systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mmHg. Note: serial blood pressure readings are only required if the initial reading is elevated;
• Anaemia (haemoglobin \< lower limit of normal for sex).
• Clinically significant 12-lead ECG abnormalities at the screening visit as determined by the Investigator.
• Concomitant consumption of any other medication regularly, with the exception of vitamins or minerals.
• Consumption of drugs with either enzyme-inducing properties, such as rifampicin and St John's Wort, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase or CYP3A4 inhibitors, such as erythromycin and clarithromycin, within 5 half-lives prior to the initial dose of study drug and throughout the treatment phase.
• Previous known or suspected drug abuse (including analgesic drugs or tranquilizers) or dependence, as defined by DSM-IV, or history of alcohol abuse or excessive intake of alcohol, defined as regular weekly intake of \>15 units for men and \>10 units for women (1 unit= 25ml spirits,125ml wine, 250ml beer or lager).
• Positive results on the urine drug screen indicative of illicit drug abuse or inconsistent with medication history, or alcohol breath test indicative of alcohol abuse.
• History of hepatitis B or C, or other forms of non-infectious liver disease.

Sponsors & Collaborators

• iX Biopharma Ltd.: lead
• Linear Clinical Research: collaborator

Study Sites (1)

Linear Clinical Research

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: August 1, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)