A Pivotal Randomised, Open-Label 3-Way Crossover Study To Demonstrate Bioequivalence Of The Sildenafil Citrate Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil Citrate 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
Abstract
The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.
Conditions: Pulmonary Arterial Hypertention.
Primary outcome: Area under the curve (AUC0-T) of sildenafil plasma concentrations from time zero to the time T of last measurable concentration.; Maximum sildenafil plasma concentration (Cmax).
Enrollment: 42 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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