Study on the effect of three single ascending doses of sildenafil citrate oral film compared with placebo on blood pressure in healthy young and elderly males

Phase 1

Completed

• Conditions: Pharmacodynamic study on blood pressure and pulse rate in healthy volunteers; Not Applicable

• Registration Number: ISRCTN10466893
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-01
• Study Start: 2022-11-28
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: males, 18-45 inclusive (young) versus =65 (elderly) years old
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: the ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate 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
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
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the active principle (PDE5 inhibitors) 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, hematological, 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 medications and herbal remedies for 2 weeks before the screening visit
7. Nitrates: treatment with nitrates for 2 weeks before the screening visit
8. 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
9. Blood donation: blood donations for 3 months before this study
10. 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)
11. Drug test: positive result at the drug test at screening or day-1
12. Alcohol test: positive alcohol breath test at day -1
13. 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