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Spanish Black Radish product

Phase 1

Healthy | Unknown | Other |Standard BioTools Inc.|Last Updated: May 14, 2014

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
UNCONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02137590An Open Label Pilot Study to Evaluate the Efficacy of Spanish Black Radish on the Induction of Phase I and Phase II EnzymesPHASE1 COMPLETED 20Sep 1, 2011Nov 1, 2011May 14, 20141 Canada
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Study Endpoints
Primary Endpoints
Effect on Phase I and II enzymes
4 weeks

The effect on phase I and phase II enzyme activity determined by measuring plasma and urine acetaminophen metabolite concentrations Subjects will ingest 1000 mg of acetaminophen. Blood will be collected at 0, 2, 4, 6 and 8 hours after acetaminophen dosage for the analysis of plasma acetaminophen metabolites. These measurements will be performed prior to and after 4 weeks of treatment with Spanish Black Radish product.

Secondary Endpoints
Assessment of Hormone Levels
4 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Spanish Black RadishEXPERIMENTALSpanish Black Radish product
Interventions
NameTypeDescription
Spanish Black Radish productDIETARY_SUPPLEMENT -
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Eligibility Criteria
Age Range25 Years — 35 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male age 25 - 35 years * BMI 18 - 25 kg/m2 * Healthy as determined by laboratory results, medical history * Agrees to avoid the consumption of cruciferous vegetables for 14 days prior to baseline and during the study treatment period * Has given voluntary, written, informed co...

Countries:Canada
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