Pharmacokinetics of a novel sildenafil orodispersible film administered by the supralingual and the sublingual route to healthy me

Phase 1

Completed

• Conditions: Erectile Dysfunction; Urological and Genital Diseases; Erectile dysfunction

• Registration Number: ISRCTN52182476
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

2018 results in https://dx.doi.org/10.1007%2Fs40261-018-0665-x

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-13
• Study Start: 2020-11-25
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1. Signed written informed consent before inclusion in the study
2. Male participants aged between 18-45 years inclusive
3. Body Mass Index (BMI) between 18.5-30 kg/m² inclusive
4. Systolic blood pressure between 100-139 mmHg, diastolic blood pressure between 50-89 mmHg, heart rate between 50-90 bpm (all measured after 5 min at rest in the sitting position)
5. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to co-operate with the investigator, and to comply with the requirements of the entire study

Exclusion Criteria

1. Clinically significant abnormalities on electrocardiogram (12-lead ECG in supine position)
2. Clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Clinically significant abnormal laboratory values indicative of physical illness
4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients, or history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
5. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could 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); or history of ophthalmologic diseases like non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Plasma sildenafil maximum serum concentration (Cmax) and area under the plasma drug concentration-time curve (AUC0-t) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h

Secondary Outcome Measures

Name	Time	Method
<br> 1. Plasma sildenafil time take to reach Cmax (tmax), relative bioavailability (Frel), and, if feasible, area under the plasma concentration-time curve from time zero to infinity (AUC0-8), elimination half-life (t1/2), and terminal disposition rate constant/terminal rate constant (?z) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h<br> 2. Plasma N-desmethyl-sildenafil time take to reach Cmax (tmax), area under the plasma drug concentration-time curve (AUC0-t), relative bioavailability (Frel), and, if feasible, area under the plasma concentration-time curve from time zero to infinity (AUC0-8), elimination half-life (t1/2), and terminal disposition rate constant/terminal rate constant (?z) are measured from plasma samples taken at baseline, and 6, 15, 30, and 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h<br>