ISRCTN13297409
Completed
Phase 1
Single Dose Crossover Comparative Bioavailability Study under Fasting Conditions and Food Effect Study of Sildenafil 100 mg Oral Films Versus Viagra® (Sildenafil) Tablets in Healthy Male Volunteers
IBSA Institut Biochimique S.A.0 sites45 target enrollmentStarted: September 4, 2018Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- IBSA Institut Biochimique S.A.
- Enrollment
- 45
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1\. Aged 18\-45 years
- •2\. BMI of 18\.5 \- 30\.0 kg/m²
- •3\. Non\-smoker or ex\-smoker
- •4\. No clinically significant diseases or findings upon physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, lipid profile, ECG and urinalysis)
- •5\. Provided signed informed consent
Exclusion Criteria
- •1\. Presence or history within 28 days of any tongue piercings
- •2\. Presence of partials, braces or dentures
- •3\. History of significant hypersensitivity to sildenafil or related products (including excipients of formulations)
- •4\. History of severe hypersensitivity reactions to any drugs
- •5\. Significant gastrointestinal, liver or kidney disease, or any other conditions known to:
- •5\.1\. Interfere with the absorption, distribution, metabolism or excretion of drugs
- •5\.2\. Potentiate or predispose to undesired effects such as severe liver failure, acute or chronic liver dysfunction or cholestatic jaundice
- •6\. History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability
- •7\. Significant cardiovascular, pulmonary, hematological, neurological, psychiatric, endocrine, immunological or dermatological disease
- •8\. Suicidal tendencies, severe depression, state of confusion or other clinically relevant psychiatric diseases
Investigators
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