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Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable Tablets 5mg Under Fasted Conditions

NCT01931501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-08-29

No results posted yet for this study

Summary

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5 mg tablet. Dosing periods were separated by a washout period during fasted study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

  • Healthy

Interventions

DRUG

Torrent's Montelukast Sodium Chewable Tablets 5mg

DRUG

Singulair® (Montelukast Sodium) Chewable Tablets 5mg

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED

Eligibility

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

Timeline & Regulatory

Primary Completion
2008-02-29

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 NCT01931501 on ClinicalTrials.gov