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Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition

NCT01691469 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-09-24

No results posted yet for this study

Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.

Conditions

  • Healthy

Interventions

DRUG

Montelukast sodium

Montelukast Sodium Oral Granules 4mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • A. Jayachandra Reddy, Dr. · Axis Clinicals Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-01-31
Completion
2011-02-28

Countries

  • India

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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 NCT01691469 on ClinicalTrials.gov