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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02850718




Registration number
NCT02850718
Ethics application status
Date submitted
12/04/2016
Date registered
1/08/2016
Date last updated
19/08/2016

Titles & IDs
Public title
A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer
Scientific title
A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer
Secondary ID [1] 0 0
SIL-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sublingual Sildenafil
Treatment: Drugs - Oral Sildenafil

Experimental: Period 1: Sublingual wafer - Subjects receive receive a single dose of 50 mg sublingual sildenafil followed by plasma sampling for 14 hours.

Active Comparator: Period 2: Oral comparator - Subjects receive a single dose of 50 mg oral sildenafil (Viagra) followed by plasma sampling for 14 hours.


Treatment: Drugs: Sublingual Sildenafil
50 mg sildenafil sublingual wafer.

Treatment: Drugs: Oral Sildenafil
50 mg oral sildenafil (Viagra)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sildenafil plasma concentrations
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Number of patients with treatment-related adverse events
Timepoint [1] 0 0
1 week

Eligibility
Key inclusion criteria
1. Voluntarily provides signed, written, and dated informed consent prior to any
study-specific procedures.

2. Healthy male volunteers aged 18-50 years inclusive.

3. In good general health without clinically significant haematological, cardiac,
respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant
disease, as determined by the Principal Investigator.

4. Sufficient access for venous cannulation to withdraw blood as per the study design.

5. Body mass index (BMI) of =19 to = 30kg/m2 (inclusive).

6. Participant is deemed able to read and understand English in order to communicate with
research staff and complete protocol required questionnaires and forms.

7. Able to refrain from smoking while at the research unit.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Past history of hypersensitivity to sildenafil, any of its excipients, or severe
allergic or anaphylactic reaction to any other drug.

2. 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:

1. History of priapism;

2. History of easy fainting or symptomatic postural hypotension;

3. Standing or supine systolic blood pressure < 90mmHg or diastolic blood pressure <
50mm Hg or postural drop of >30mm Hg;

4. History of myocardial infarction or clinically significant cardiac disease
including cardiac arrhythmia;

5. History of retinitis pigmentosa or optic neuropathy or other risk factors of
non-arteritic anterior ischaemic optic neuropathy (NAION);

6. 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;

7. Anaemia (haemoglobin < lower limit of normal for sex).

3. Clinically significant 12-lead ECG abnormalities at the screening visit as determined
by the Investigator.

4. Concomitant consumption of any other medication regularly, with the exception of
vitamins or minerals.

5. 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.

6. 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).

7. 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.

8. History of hepatitis B or C, or other forms of non-infectious liver disease.

9. 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.

10. Clinically significant plasma AST, ALT and ALP tests (defined as =1.5 times the upper
limit of normal).

11. Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or
hepatitis C virus (HCV) infection at screening.

12. Prevalent abnormality in the oral cavity which may alter sublingual drug absorption
(e.g. recurrent oral ulceration, lichen planus, or xerostomia).

13. Any other condition which, in the opinion of the Investigator, makes the volunteer
unsuitable for the study.

14. 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.

15. Member or relative of study staff or the Sponsor directly involved in the study.

16. Previous participation in this study.

17. 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
iX Biopharma Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Linear Clinical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test
sublingual sildenafil wafer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02850718
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries