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

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.
• +9 more criteria