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Reminyl

Phase 1

Fasting | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 30, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Reminyl · 2 trials · 2 indications

Phase 1 2
NCT01372280Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting ConditionFasting
COMPLETED28 Analytics
NCT01372306Galantamine Bioequivalence Study of Dr. Reddy's Under Fed ConditionFed
COMPLETED24 Analytics
PHASE1COMPLETED
Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting Condition
FastingUnlock trial analytics
PHASE1COMPLETED
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
FedUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence on Cmax and AUC parameters
2 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GalantamineEXPERIMENTALGalantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited
ReminylACTIVE_COMPARATORReminyl 4 mg tablets of Janssen Pharmaceutical Products

Interventions

NameTypeDescription
ReminylDRUGGalantamine Hydrobromide Tablets 4 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified: * Healthy adult male volunteers, 18-55 years of age; * Weighing at least 60 kg and within 15% of their ideal weights (Table of "Des...

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Frequently asked questions about Reminyl

What is Reminyl used for?

Reminyl is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development for use in fed and fasting conditions. The drug is being studied in healthy volunteers to assess its effects under these different dietary states.

Who makes Reminyl?

Reminyl is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.

What phase is Reminyl in?

Reminyl is in Phase 1 clinical development. It has completed one trial with a total enrollment of 28 participants. The drug is still investigational and has not been approved for any medical use.

What clinical trials is Reminyl in?

Reminyl has been studied in two completed Phase 1 clinical trials. NCT01372280 evaluated the drug under fasting conditions in 28 healthy male volunteers, and NCT01372306 evaluated it under fed conditions in 24 healthy male volunteers. Both trials were active-controlled and not double-blinded.

Is Reminyl the same as galantamine?

Reminyl is a brand name for the drug galantamine. The clinical trials conducted by Dr. Reddy's Laboratories Ltd are titled as galantamine bioequivalence studies, indicating that Reminyl contains galantamine as its active ingredient.