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Bioequivalence Study of Klaribact (Clarithromycin) 500 mg, Film Coated Tablet

NCT05436769 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-09-07

No results posted yet for this study

Summary

This is An Open Label, Randomized, Single Dose, Two Way Cross over, Two Period, Two Treatment, Two Sequence Bioequivalence Study to compare the rate and extent of absorption of Klaribact FC Tablet (Clarithromycin 500 mg) with Reference Product, Klaricid FC Tablet (Clarithromycin 500 mg) in healthy adult male subjects under fasting condition.

Conditions

  • Healthy Volunteers
  • Bioequivalence Study

Interventions

DRUG

Klaribact 500 mg Clarithromycin Tablet

A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.

DRUG

Klaricid 500 mg Clarithromycin Tablet

A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.

Sponsors & Collaborators

  • Merck Pvt. Ltd, 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
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-23
Primary Completion
2012-11-02
Completion
2012-12-25

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 NCT05436769 on ClinicalTrials.gov