A study to assess the amount of sildenafil that reaches the blood circulation after administration of an oral film dissolvable in the mouth for treating erectile dysfunction in comparison to the marketed tablet Viagra®, both taken by healthy men under fed conditions

Phase 1

Completed

• Conditions: Sildenafil for erectile dysfunction; Mental and Behavioural Disorders

• Registration Number: ISRCTN15394603
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-01-28
• Study Start: 2023-01-10
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: males, 18-55 years old inclusive
3. Body Mass Index: 18.5-30 kg/m² inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study.

Exclusion Criteria

1. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities; out of range intervals (PR <110 msec, PR >200 msec, QRS <60 msec, QRS >110 msec and QTc > 440 msec)
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; presence or history (within 28 days) of any tongue piercings; presence of any partials, braces or dentures
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; history of vision or hearing problems related to drugs of the PDE5 inhibitor pharmacological class; history of priapism; anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease); history of ophthalmologic diseases like non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa
6. Medications: medications, including over the counter (OTC) medications and herbal remedies for 2 weeks before the start of the study. Organic nitrates will not be allowed for 28 days before screening
7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
8. Blood donation: blood donations for 3 months before this study
9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day, defined according to the USDA Dietary Guidelines 2015-2020], caffeine (>5 cups coffee/tea/day) or tobacco abuse (?10 cigarettes/day)
10. Drug test: positive result at the drug test at screening or day-1
11. Alcohol test: positive alcohol breath test at day -1
12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians.

Study & Design

• Study Type: Interventional
• Study Design: Not specified