ISRCTN79039906
Completed
Phase 1
Single dose crossover comparative bioavailability study of tadalafil 20 mg oral film and soft-gel capsule versus Cialis® (tadalafil) 20 mg tablet in healthy male volunteers
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- IBSA Institut Biochimique SA
- Enrollment
- 15
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1\. Male, at least 18 years of age but not older than 50 years
- •2\. Non\- or ex\-smokers
- •3\. Body mass index (BMI) within 18\.5 to 30\.0 kg/m2, inclusively
- •4\. No clinically significant abnormality found in the 12\-lead electrocardiogram (ECG) performed at study entry
- •5\. Healthy according to medical history, complete physical examination (including vital signs and penis examination) and laboratory tests (general biochemistry including lipid profile, hematology and urinalysis)
Exclusion Criteria
- •Volunteers presenting any of the following will not be included in the study:
- •1\. Presence or history within 28 days of any tongue piercings
- •2\. Presence of partials, braces or dentures
- •3\. Seated pulse rate less than 50 Beats per Minute (bpm) or more than 100 bpm at screening
- •4\. Seated blood pressure below 100/60 mmHg at screening
- •5\. Seated blood pressure higher than 140/90 mmHg at screening and prior to 1st dosing
- •6\. History of significant hypersensitivity to tadalafil or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •7\. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- •8\. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- •9\. Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
Investigators
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