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Altace

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 Trials3
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00828321Ramipril 10 mg Capsule in Healthy Subjects Under Fasting ConditionsPHASE1 COMPLETED 40 — — Aug 1, 2004Oct 1, 2004Aug 19, 20242 Canada
NCT00829452Ramipril 10 mg Capsule in Healthy Subjects Under Fasting ConditionsPHASE1 COMPLETED 40 — — Aug 1, 2004Oct 1, 2004Aug 19, 20242 Canada
NCT00829530Ramipril 10 mg Capsule in Healthy Subjects Under Fed ConditionsPHASE1 COMPLETED 40 — — Aug 1, 2004Oct 1, 2004Aug 19, 20242 Canada
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Study Endpoints
Primary Endpoints
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril
Blood samples collected over a 72 hour period.

Bioequivalence based on Cmax of Ramipril.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)of Ramipril
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t of Ramipril.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)of Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t for Ramipril.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-inf.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-inf.

Secondary Endpoints
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramiprilat.
Blood samples collected over a 72 hour period.
AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time 72 Hours)of Ramiprilat.
Blood samples collected over a 72 hour period.
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.
Blood samples collected over a 72 hour period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Ramipril 10 mg capsuleDRUG1 x 10 mg
Altace® 10 mg capsuleDRUG1 x 10 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male or non-childbearing potential female, light smoker of non-smoker 18 years of age and older. * Capable of consent * Non-childbearing potential female subject is defined as follows: * Post-menopausal state: absence of menses for 12 months prior to drug administration or hys...

Countries:Canada
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