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Ramipril

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Ramipril · 2 trials · 1 indication

Phase 1 2
NCT01164774Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting ConditionsHealthy
COMPLETED54 Analytics
NCT01164761Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting ConditionsHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting Conditions
HealthyUnlock trial analytics

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 to 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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