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Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fasted Conditions

NCT01928056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-08-23

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 10 mg tablet and Innovator's(Merck)Singulair 10 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 Tablets 10 mg

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

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

Timeline & Regulatory

Primary Completion
2009-12-31

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 NCT01928056 on ClinicalTrials.gov