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Nateglinide

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 13, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment126

FDA Designations

No designations recorded

Clinical trial landscape

Nateglinide · 2 trials · 1 indication

Phase 1 2
NCT01159158Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting ConditionHealthy
COMPLETED68 Analytics
NCT01160029Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed ConditionHealthy
COMPLETED58 Analytics
PHASE1COMPLETED
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NateglinideEXPERIMENTALNateglinide Tablets 120 mg of Dr. Reddys Laboratories Limited
StarlixACTIVE_COMPARATORStarlix Tablets 120 mg of Novartis

Interventions

NameTypeDescription
NateglinideDRUGNateglinide Tablets 120 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Male or female, smoker or non-smoker, 18 years of age and older. * Capable of consent Exclusion Criteria: Subjects to whom any of the following applies will be excluded from the study: * Clinically significant illnesses within 4 weeks prior to the administration of the stud...

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