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Bioequivalence Study of Klaribact 125mg/5ml, Suspension

NCT05340452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-29

No results posted yet for this study

Summary

A two way crossover BE study will be performed to evaluate the comparative bioavailability of Klaribact (Clarithromycin 125 mg/5ml) suspension (Merck Pvt. Ltd, Pakistan) with Klaricid (Clarithromycin 125mg/5ml) suspension (Abbot Laboratories Pakistan Limited) at the clinical site (CBSCR), Karachi Pakistan.

Conditions

  • Healthy

Interventions

DRUG

Klaribact 125mg/5ml Suspension

one single 20 mL dose (500mg) of the test drug will be administered to the volunteers

DRUG

Klaricid 125mg/5ml Suspension

one single 20 mL dose (500mg) of the Reference drug will be administered to the volunteers

Sponsors & Collaborators

  • Merck (Pvt.) Limited, Pakistan

    collaborator UNKNOWN

  • Center for Bioequivalence Studies and Clinical Research (CBSCR), HEJ Research Institute of chemistry, University of Karachi

    collaborator UNKNOWN

  • University of Karachi

    lead OTHER

Principal Investigators

  • Muhammad Shah, PhD · Center for bio-equivalence studies and clinical research (CBSCR)

  • Naghma R Hashmi, PhD · Center for bio-equivalence studies and clinical research

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
2013-06-29
Primary Completion
2013-07-08
Completion
2013-10-25

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 NCT05340452 on ClinicalTrials.gov