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sildenafil CT

Phase 1

Erectile Dysfunction | Small molecule | Endocrine |Viatris Inc.|Trials Updated: Feb 1, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

sildenafil CT clinical trials

sildenafil CT · 1 trial · 1 indication

Phase 1 1
NCT00904748A Relative Bioavailability Study Between Two Formulations Of Sildenafil CitrateErectile Dysfunction
COMPLETED47 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Erectile Dysfunction
NCT0090474847
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Study Endpoints

Primary Endpoints

Area Under the Curve (AUC 0-t)
Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose

Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms\*hour/milliliter (ng\*hr/mL).

Maximum Plasma Concentration (Cmax)
Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose

Maximum plasma concentration measured in nanograms per milliliter (ng/mL).

Secondary Endpoints

Area Under the Curve From 0 to Infinity (AUC 0-inf )
Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
Half-life (T 1/2)
Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Test 1EXPERIMENTAL -
Test 2EXPERIMENTAL -
ReferenceACTIVE_COMPARATOR -

Interventions

NameTypeDescription
sildenafil citrate 100 mg CTDRUGsildenafil citrate 100 mg CT, single dose without water
Viagra®DRUGsildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index higher or equal to 18,5 and lower or equal than 29,9 kg/m2. * Good health conditions or without significant disease, at medical discretion, according to the rules defined in the Protocol, and evaluations undergone: clinical history, pulse and blood pressure mea...

Countries:Brazil
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