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Altace

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

Altace · 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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Frequently asked questions about Altace

What is Altace?

Altace is the brand name for ramipril, a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development, studied in healthy volunteers for bioavailability purposes. Two Phase 1 trials have been completed, with a total enrollment of 108 participants.

What is Altace used for?

Altace is being studied in healthy volunteers to assess the bioavailability of ramipril 10 mg capsules under fasting and non-fasting conditions. These are pharmacokinetic studies, not therapeutic efficacy trials. The drug is in Phase 1 clinical development and is not yet approved for any medical condition.

Who makes Altace?

Altace is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 bioavailability studies of ramipril 10 mg capsules in healthy male volunteers in India.

What phase is Altace in?

Altace is in Phase 1 clinical development. Two Phase 1 trials have been completed, both focusing on bioavailability of ramipril 10 mg capsules. The drug is investigational and has not been approved by regulatory authorities. No active trials are currently listed.

What clinical trials is Altace in?

Altace has two completed Phase 1 trials: NCT01164761, a bioavailability study under fasting conditions, and NCT01164774, a bioavailability study under non-fasting conditions. Both enrolled 54 healthy male volunteers aged 18 years and older in India, with active-controlled design.

Is Altace the same as ramipril?

Yes, Altace is the brand name for ramipril. The clinical trials for Altace specifically study ramipril 10 mg capsules. Ramipril is the active pharmaceutical ingredient, while Altace is the proprietary name used by the developer.