Study of tadalafil 20 mg oral film and soft-gel capsules versus Cialis® (tadalafil) 20 mg tablet in healthy male volunteers

INTERVENTION: 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 mg OF Test‐2: 1 x Tadalafil IBSA 20 mg soft‐gel capsule Reference: 1 x Cialis® (tadalafil) 20 mg tablet The drug administrations were separated by a wash‐out of 14 days. The investigational products were administered on 05/08/2017 for period 1, on 19/08/2017 for period 2, and 02/09/2017 for period 3. In each study period, 22 blood samples were collected for each subject, starting from right before drug administration and up to 72 hours thereafter. Tadalafil was measured in human plasma using a validated HPLC with MS/MS method (Limit of Quantification = 5.00 ng/mL). CONDITION: Bioavailability study of tadalafil 20 mg oral film and soft‐gel capsule versus Cialis® (tadalafil) 20 mg tablet ; Not Applicable PRIMARY OUTCOME: 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 OUTCOME: 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 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)