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Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fasting Conditions

NCT01884896 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-06-24

No results posted yet for this study

Summary

This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.

Conditions

  • Fasting

Interventions

DRUG

Metoprolol Succinate ER Tablet 200 mg

1 \* 200 mg tablet per day

DRUG

'TOPROL-XL®' ER Tablets 200 mg

1 \* 200 mg tablet per day

Sponsors & Collaborators

  • IPCA Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Manish Singhal, M.B.B.S · Cliantha Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884896 on ClinicalTrials.gov