The purpose of this study is to assess the bioequivalence of Sildenafil ODF 50 mg to Viagra® tablet 50 mg under fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
50 mg tablet on Day 1 of each period
50 mg ODF on Day 1 of each period
50 mg ODF on Day 1 of each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time frame: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: Baseline up to 2 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Laboratory parameters included: hematology, chemistry and urine. Clinical significance of laboratory parameters was determined at the investigator's discretion.
Time frame: Baseline up to 2 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs are obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.
Time frame: Baseline up to 2 days after last dose of study medication
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Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings
Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Time frame: Baseline up to 2 days after last dose of study medication