drugset / Trial / NCT00904748

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

NCT00904748 ↗

Phase 1 Completed 47 enrolled Viatris Inc.
RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.

Timeline

Start
2010-01
Primary completion
2010-03
Completion
2010-03

Outcome

Mixed primary results

registry Test 1: 100 mg Chewable, Without Water vs Reference: 100 mg Coated, With Water; ratio between geometric means 98.68 (90% CI 92.03 to 105.82); ANOVA NCT00904748 ↗

registry Test 2: 100 mg Chewable, With Water vs Reference: 100 mg Coated, With Water; ratio between geometric means 97.23 (90% CI 90.67 to 104.26); ANOVA NCT00904748 ↗

registry Test 1: 100 mg Chewable, Without Water vs Reference: 100 mg Coated, With Water; ratio between geometric means 80.83 (90% CI 72.38 to 90.26); ANOVA NCT00904748 ↗

registry Test 2: 100 mg Chewable, With Water vs Reference: 100 mg Coated, With Water; ratio between geometric means 78.76 (90% CI 70.53 to 87.96); ANOVA NCT00904748 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sildenafil Unknown 100 mg —

Indications