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Bioequivalence Study of Levomerc 500 mg Tablets

NCT05339295 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-09-07

No results posted yet for this study

Summary

An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting condition.

Conditions

  • Healthy
  • Pharmacokintetics

Interventions

DRUG

Levofloxacin 500mg

A single dose consisting of one tablet of either test drug (Levomerc 500 mg) or reference drug (Tavanic 500mg) administered to each of the subjects in both Period.

Sponsors & Collaborators

  • Merck Pvt. Ltd, Pakistan

    collaborator UNKNOWN

  • Center for bioequivalence studies and clinical reseach (CBSCR), ICCBS, University of Karachi

    collaborator UNKNOWN

  • University of Karachi

    lead OTHER

Principal Investigators

  • Prof. Dr. Muhammad R Shah, PhD · CBSCR, ICCBS, University of Karachi

  • Naghma Hashmi (Co-PI), PhD · CBSCR, ICCBS, University of Karachi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-07-11
Primary Completion
2012-07-20
Completion
2012-09-20

Countries

  • Pakistan

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 NCT05339295 on ClinicalTrials.gov