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SPO1101

Phase 1

Healthy | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Jan 17, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment115
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01769638Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean VolunteersPHASE1 COMPLETED 115 — — Sep 1, 2011Dec 1, 2011Jan 17, 2013 - —
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Study Endpoints
Primary Endpoints
AUC
0 (predose), 0.017, 0.05, 0.117, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours after the dose
Secondary Endpoints
Cmax
0 (predose), 0.017, 0.05, 0.117, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours after the dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SPO1101EXPERIMENTAL -
SPO1101DEXPERIMENTAL -
Interventions
NameTypeDescription
SPO1101DRUGA single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 50mg), with a 7-day washout period between the formulations.
SPO1101DDRUGA single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 100mg), with a 7-day washout period between the formulations.
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Eligibility Criteria
Age Range20 Years — 50 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Eligible subjects were healthy male volunteers between the ages of 20 and 50 years and within 20% of their ideal body weight, and * With no congenital abnormality or chronic disease. Exclusion Criteria: Key exclusion criteria included: * history of cardiovascular, pulmonary...

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