- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850718
A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer
August 18, 2016 updated by: iX Biopharma Ltd.
A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test sublingual sildenafil wafer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Healthy volunteers will complete two inpatient study periods and receive either sublingual wafer sildenafil or oral sildenafil.
Plasma samples and adverse events will be collected.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Western Australia
-
Perth, Western Australia, Australia, 6009
- Linear Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Clinically significant abnormalities in clinical chemistry, haematology, urinalysis, or serology results at screening that, in the opinion of the Investigator, puts the volunteer at risk for study participation.
- Clinically significant plasma AST, ALT and ALP tests (defined as ≥1.5 times the upper limit of normal).
- Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening.
- Prevalent abnormality in the oral cavity which may alter sublingual drug absorption (e.g. recurrent oral ulceration, lichen planus, or xerostomia).
- Any other condition which, in the opinion of the Investigator, makes the volunteer unsuitable for the study.
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to return for follow up visits on schedule.
- Member or relative of study staff or the Sponsor directly involved in the study.
- Previous participation in this study.
- Has received another investigational agent or new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to the Screening visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Period 1: Sublingual wafer
Subjects receive receive a single dose of 50 mg sublingual sildenafil followed by plasma sampling for 14 hours.
|
50 mg sildenafil sublingual wafer.
Other Names:
|
Active Comparator: Period 2: Oral comparator
Subjects receive a single dose of 50 mg oral sildenafil (Viagra) followed by plasma sampling for 14 hours.
|
50 mg oral sildenafil (Viagra)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sildenafil plasma concentrations
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with treatment-related adverse events
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
April 12, 2016
First Submitted That Met QC Criteria
July 27, 2016
First Posted (Estimate)
August 1, 2016
Study Record Updates
Last Update Posted (Estimate)
August 19, 2016
Last Update Submitted That Met QC Criteria
August 18, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIL-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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