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Metoprolol

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Sep 28, 2012

Target and mechanism

ModalitySmall molecule

Also known as Metoprolol Succinate

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Metoprolol · 2 trials · 1 indication

Phase 1 2
NCT01694797Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting ConditionHealthy
COMPLETED48 Analytics
NCT01673997Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting ConditionsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition
Healthy
NCT0169479748
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PHASE1COMPLETED
Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting Conditions
Healthy
NCT0167399748
Unlock trial analytics

Study Endpoints

Primary Endpoints

Area under curve (AUC)
Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Metoprolol Succinate ER Tablets, 50 mgEXPERIMENTALMetoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd
TOPROL-XL ER Tablets 50 mgACTIVE_COMPARATORTOPROL-XL ER Tablets 50 mg of AstraZeneca
Metoprolol Succinate ER Tablets, 200 mgEXPERIMENTALMetoprolol Succinate ER Tablets, 200 mg of Dr.Reddy's Laboratories Ltd
TOPROL-XL ER Tablets 200 mgACTIVE_COMPARATORTOPROL-XL ER Tablets 200 mg of AstraZeneca

Interventions

NameTypeDescription
Metoprolol SuccinateDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects were selected based on the following inclusion criteria: * Provide written informed consent. * Must be healthy, adult, human beings between 18 and 45 years of age(both inclusive) weighing at least 50 kg. * Having a body mass index between 18.5 and 24.9 (both inclusive)...

Countries:India
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