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Moexipril /hydrochlorothiazide 15/

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 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 Enrollment120
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00834067Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting ConditionsPHASE1 COMPLETED 60 — — Oct 1, 2003Nov 1, 2003Aug 20, 20242 United States
NCT00835042Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting ConditionsPHASE1 COMPLETED 60 — — Oct 1, 2003Nov 1, 2003Aug 20, 20242 United States
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Study Endpoints
Primary Endpoints
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.
Blood samples collected over a 192 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-inf.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.
Blood samples collected over a 192 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-inf.

Secondary Endpoints
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.
Blood samples collected over a 192 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.
Blood samples collected over a 192 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.
Blood samples collected over a 192 hour period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Moexipril HCl/hydrochlorothiazide 15/25 mg tabletsDRUG1 x 15/25 mg
UNIRETIC® 15/25 mg tabletsDRUG1 x 15/25 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. * Subjects will have a BMI index (body mass index) of 30 or less. Exclusion Criteria: * Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious...

Countries:United States
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