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Glimepiride

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 21, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

Glimepiride · 2 trials · 1 indication

Phase 1 2
NCT01052909Bioequivalence Study of Dr.Reddy's Laboratories Limited, Glimepiride Tablets 1 mg Under Fasting ConditionHealthy
COMPLETED44 Analytics
NCT01053689Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed ConditionHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Bioequivalence Study of Dr.Reddy's Laboratories Limited, Glimepiride Tablets 1 mg Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence study of Dr. Reddy's Laboratories Limited, Glimepiride tablets 1 mg under Fasting condition
4 months
Bioequivalence study of Dr. Reddy's Laboratories Limited, Glimepiride tablets 1 mg under Fed condition
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GlimepirideEXPERIMENTALGlimepiride tablets 1 mg of Dr. Reddy's Laboratories Limited
AmarylACTIVE_COMPARATORAmaryl 1 mg tablets of Aventis Pharmaceuticals Inc

Interventions

NameTypeDescription
GlimepirideDRUGGlimepiride tablets 1 mg
Glimepiride tablets 1 mgDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or non-child-bearing potential female,smoker and or non-smoker,18 years of age and older. * Capable of consent. * Non-child-bearing potential female subject: * Post-menopausal state:absence of menses for 12 months prior to drug. administration or hysterectomy with bilater...

Countries:Canada
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