A study comparing the level of absorption of sildenafil from Sildenafil 100 mg Oral Films versus Viagra® 100 mg tablets and the effect of food on absorption of sildenafil from Sildenafil 100 mg Oral Films in healthy me

Phase 1

Completed

• Conditions: Erectile dysfunction; Urological and Genital Diseases

• Registration Number: ISRCTN13297409
• Lead Sponsor: IBSA Institut Biochimique S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-22
• Study Start: 2018-09-04
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 45

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
9. History of or disposition to seizures
10. Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities
11. Use of organic nitrate medications in the previous 28 days
12. History of vision or hearing problems related to the PDE5 inhibitor pharmacological class
13. Presence or history of priapism
14. Anatomical deformation of the penis
15. History of ophthalmological disease, such as non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa
16. Known presence of rare hereditary problems of:
16.1. Galactose and/or lactose intolerance
16.2. Lactase deficiency
16.3. Glucose-galactose malabsorption
17. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol (acute or chronic))
18. Positive screening for alcohol and/or drug abuse
19. Use of enzyme modifying drugs in the previous 28 days, including:
19.1. Strong inhibitors of CYP enzymes (e.g. cimetidine, fluoextine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals)
19.2. Strong inducers of CYP enzymes (e.g. barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St Johns Wort)
20. History of tuberculosis and/or prophylaxis for tuberculosis
21. Positive results to the following tests:
21.1. HIV Ag/Ab Combo
21.2. Hepatitis B surface antigen (HBsAG (B) (hepatitis B))
21.3. Hepatitis C Virus (HCV (C))
22. Taken sildenafil in the previous 28 days
23. Donated 500 ml or more of blood in the previous 56 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (Cmax, AUC, Tmax, Thalf, ?Z) for the absorption of sildenafil. The concentration of sildenafil in plasma is measured at the following time-points: pre-dose (0) and 10, 15, 20, 30, 40, 50 min, 1 h, 1:20, 1:40, 2, 2:20, 2:40, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after the dose in each of the three study periods. Each study period is separated by at least 7 calendar days. Plasma samples are assayed for sildenafil using a validated high performance liquid chromatography (HPLC) method with tandem mass spectrometry (MS/MS) detection. The lower limit of quantitation (LOQ) and upper limit of quantitation (ULQ) are 1.00 and 1000.00 ng/ml for sildenafil.