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Altace

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 19, 2010

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_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01164774Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting ConditionsPHASE1 COMPLETED 54Oct 1, 2005Nov 1, 2005Jul 19, 20101 India
NCT01164761Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting ConditionsPHASE1 COMPLETED 54Sep 1, 2005Oct 1, 2005Jul 19, 20101 India
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Study Endpoints
Primary Endpoints
Bioavailability based on Cmax and AUC parameters
2 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RamiprilEXPERIMENTALRamipril 10 mg capsules of Dr. Reddy's Laboratories Limited
AltaceACTIVE_COMPARATORAltace@ 10 mg capsules of Kings Pharmaceuticals, USA
Interventions
NameTypeDescription
RamiprilDRUGRamipril 10 mg Capsules of Dr. Reddy's Laboratories Limited
AltaceDRUGAltace@ 10 mg capsules of Kings Pharmaceuticals, USA
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India. 2. Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2 3. Not having any significant diseases...

Countries:India
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