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Ursodiol

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment172
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00909610Ursodiol Tablets 500 mg Under Fasting ConditionsPHASE1 COMPLETED 80 — — Dec 1, 2006Jan 1, 2007Aug 19, 20241 Canada
NCT00909753Ursodiol 500 mg Tablets Under Fed ConditionsPHASE1 COMPLETED 92 — — Sep 1, 2006Oct 1, 2006Aug 19, 20241 Canada
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Study Endpoints
Primary Endpoints
Cmax - Maximum Observed Concentration - for Total Ursodiol
Blood samples collected over 72 hour period

Bioequivalence based on Cmax

AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-72

Cmax for Baseline Corrected Total Ursodiol
Blood samples collected over 72 hour period

Bioequivalence based on Cmax

AUC0-72 for Baseline Corrected Total Ursodiol
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-72

Cmax for Unconjugated Ursodiol
Blood samples collected over 72 hour period

Bioequivalence based on Cmax

AUC0-72 for Unconjugated Ursodiol
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-72

Cmax for Unconjugated Ursodiol - Baseline Corrected
Blood samples collected over 72 hour period

Bioequivalence based on Cmax

AUC0-72 for Unconjugated Ursodiol - Baseline Corrected
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-72

AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-72

Cmax for Total Ursodiol - Baseline Corrected
Blood samples collected over 72 hour period

Bioequivalence based on Cmax

AUC0-72 for Total Ursodiol - Baseline Corrected
Blood samples collected over 72 hour period

Bioequivalence based on AUC0-72

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Ursodiol (test) FirstEXPERIMENTALUrsodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg dosed in second period.
Urso Forte™ (reference) FirstACTIVE_COMPARATORUrso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
Interventions
NameTypeDescription
UrsodiolDRUGUrsodiol Tablets, 500 mg
Urso Forte™DRUGUrso Forte™ Tablets, 500 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, non-smoking male and female subjects, 18 years of age or older. * BMI ≥ 19 and ≤ 30. * Negative for: 1. HIV. 2. Hepatitis B surface antigen and Hepatitis C antibody. 3. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodia...

Countries:Canada
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