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Rivastigmine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 13, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

Rivastigmine · 2 trials · 1 indication

Phase 1 2
NCT01146041Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed ConditionsHealthy
COMPLETED44 Analytics
NCT01146067Bioequivalence Study of Rivastigmine 1.5 mg Capsules Under Fasting ConditionsHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Rivastigmine 1.5 mg Capsules Under Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RivastigmineEXPERIMENTALRivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited
exelonACTIVE_COMPARATORExelon 1.5 mg capsules of Novartis

Interventions

NameTypeDescription
RivastigmineDRUGRivastigmine 1.5 mg Capsules
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion criteria * Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Inc. Web site, Anapharm Inc. volunteer's database). Subjects must meet all of the following criteria in order t...

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Frequently asked questions about Rivastigmine

What is Rivastigmine?

Rivastigmine is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers in bioequivalence trials.

What is Rivastigmine used for?

Rivastigmine has been studied in healthy volunteers in clinical trials. The trials were bioequivalence studies, which are designed to compare the drug's absorption and effects with a reference product. The drug is not yet approved for any specific medical condition.

Who makes Rivastigmine?

Rivastigmine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company has conducted clinical trials to evaluate the drug's bioequivalence in healthy subjects.

What phase is Rivastigmine in?

Rivastigmine is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Rivastigmine in?

Rivastigmine has been studied in two completed Phase 1 clinical trials: NCT01146041, a bioequivalence study of Rivastigmine capsules 1.5 mg under fed conditions, and NCT01146067, a bioequivalence study of Rivastigmine 1.5 mg capsules under fasting conditions. Each trial enrolled 44 healthy participants.

Is Rivastigmine the same as Exelon?

Rivastigmine is the generic name for a drug that is also known by the brand name Exelon. The clinical trials conducted by Dr. Reddy's Laboratories Ltd evaluated the bioequivalence of Rivastigmine capsules compared to a reference product.