Bioavailability study of tadalafil 20 mg oral film and soft-gel capsule versus Cialis® (tadalafil) 20 mg tablet Not Applicable
Conditions
Interventions
Each volunteer received the 3 treatments in 3 different study periods, according to a cross-over design. The randomization scheme was computer-generated.
Test-1: 1 x Tadalafil IBSA 20
Sponsors
IBSA Institut Biochimique SA
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 10. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases 11. Presence of out-of-range cardiac interval (PR 200 msec, QRS 110 msec and QTc > 440 msec) on the screening ECG or other clinically significant ECG abnormalities 12. Use of organic nitrate medication in the previous 28 days before day 1 of the study 13. Use of PDE 5 inhibitors (such as sildenafil) in the previous 28 days before day 1 of the study 14. Volunteer at increased risk of priapism, including subjects with sickle cell anemia, multiple, myeloma, leukemia, etc 15. Presence or history of non-arteritic anterior ischemic optic neuropathy (NAION) 16. Presence or history of anatomical deformation of the penis (i.e. angulation, cavernosal fibrosis or Peyronie’s disease) 17. Known presence of rare hereditary problems of galactose and /or lactose intolerance, lactase deficiency or glucose-galactose malabsorption 18. 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) 19. Any clinically significant illness in the previous 28 days before day 1 of this study 20. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John’s Wort), in the previous 28 days before day 1 of this study 21. Any history of tuberculosis and/or prophylaxis for tuberculosis 22. Positive screening of alcohol and/or drugs of abuse 23. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests 24. Volunteers who took tadalafil in t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile before and at different timepoints over the 72 h period after single drug administration in each of three study periods: tadalafil blood levels measured using a validated high performance liquid chromatography (HPLC) method with tandem mass spectrometry (MS/MS) detection, the lower limit of quantitation (LOQ) was 5.00 ng/mL | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events reported during the whole clinical phase, together with vital signs, ECGs and standard lab tests before and at the end of the trial | — |
Countries
Canada
Outcome results
None listed