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Bioequivalence Study of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects

NCT04873570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-09-07

No results posted yet for this study

Summary

Single oral dose, of test and reference Tablet will be administered to healthy volunteers, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose.

Conditions

  • Healthy Individuals
  • Bioequivalence Study

Interventions

DRUG

Moxifloxacin 400mg

Moxifloxacin 400mg IR tablet

Sponsors & Collaborators

  • SAMI Pharmaceutical, Karachi Pakistan

    collaborator UNKNOWN

  • Center for Bioequivalence Studies and Clinical Research

    collaborator OTHER

  • University of Karachi

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2021-06-08
Completion
2021-06-10

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 NCT04873570 on ClinicalTrials.gov