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EFFECTS OF MOXIFLOXACIN AND GEMIFLOXACIN ON BLOOD GLUCOSE AND ECG MORPHOLOGY OF EUGLYCEMICS:A CLINICAL STUDY

NCT04692623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-04-12

No results posted yet for this study

Summary

EFFECTS OF MOXIFLOXACIN AND GEMIFLOXACIN ON BLOOD GLUCOSE LEVEL OF EUGLYCEMICS:A PRE-CLINICAL AND CLINICAL STUDY.

Our aim and objectives are to:

1. To check the possible effects of Moxifloxacin and Gemifloxacin in healthy volunteers for possible effects on blood glucose levels with a subsequent shift in serum insulin level of healthy volunteer (target population).
2. ECG morphology effect. In the above entitled studies we are going to determine the effects of the above two 4th generation fluoroquinolones drugs on the blood glucose levels and ECG morphology effect.of euglycemics healthy volunteers.The drug will be gave as per approved standard adult dose.The drug is FDA approved and marketed drug.No risk is to the patient only 3-5 ml of the blood will be taken at baseline and after the drug completion at steady state concentration.

Conditions

Interventions

DRUG

Moxifloxacin 400mg

Blood will be checked for glucose levels and ECG at Baseline(Day Ist) and at Steady state Steady state(Tmax) via Glucometer and ECG machine will be used for determination of serum insulin levels.

DRUG

Gemifloxacin 320 MG

Blood will be checked for glucose levels and ECG at Baseline(Day Ist) and at Steady state(Tmax) via Glucometer and ECG machine will be used for determination of serum insulin levels.

Sponsors & Collaborators

  • Khyber Medical University Peshawar

    collaborator OTHER

  • Shaheed Benazir Bhutto University Sheringal Dir Upper

    lead OTHER

Principal Investigators

  • Abid Ullah, Ph.D Scholar · Departemt of Pharmacy,Shaheed Benazir Bhutto University,Sheringal Dir Upper,KP,Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-03-15
Completion
2021-04-01

Countries

  • Pakistan

Study Locations

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Entities

Diseases

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 NCT04692623 on ClinicalTrials.gov