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Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions

NCT01506076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-01-09

No results posted yet for this study

Summary

The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance, under fasting conditions.

Conditions

  • Fasting

Interventions

DRUG

Levocetirizine DiHCl

Levocetirizine DiHCl Tablets 5 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Sudershan Vishwanath, MD · Vimta Labs 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
2007-12-31
Primary Completion
2008-01-31
Completion
2008-01-31

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 NCT01506076 on ClinicalTrials.gov