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Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck)

NCT02479854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-06-24

No results posted yet for this study

Summary

Comparative randomized, single dose, two-way crossover open-label study To investigate the bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg chewable tablets(Merck \& Co. Inc. ), after a single oral dose administration of each to healthy adults under fasting conditions,

Conditions

  • Healthy

Interventions

DRUG

Asmakast

1 chewable tablet contains 5 mg montelukast

DRUG

Singulair

1 chewable tablet contains 5 mg montelukast

Sponsors & Collaborators

  • Sandoz

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Companies

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 NCT02479854 on ClinicalTrials.gov