MedTrace Logo

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

NCT01659905 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-01-23

No results posted yet for this study

Summary

The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fasted conditions.

Conditions

Interventions

DRUG

Montelukast

Chewable Tablet

DRUG

Singulair

5 mg Chewable Tablet

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Alan K Copa, PharmD · PRACS Institute, Ltd.

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
2008-08-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01659905 on ClinicalTrials.gov