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

• Status: Completed
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: Male

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. Identify the possible mechanism of secretion of insulin via ATP-sensitive K+ channels through power lab in comparison to a standard.

2. Determine the blood glucose, insulin and C-Peptide levels in animal model plus euglycemics using Moxifloxacin and Gemifloxacin in their recommended daily doses per oral route and to check the histomorphological features changes of the pancreatic tissue of rabbits (in vivo).

3. Translate the results of animal model and healthy volunteers for possible effects on release of insulin, peptide and subsequent shift in blood glucose level of healthy volunteer (target population).

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shaheed Benazir Bhutto University Sheringal Dir Upper
• Collaborator: Khyber Medical University Peshawar
• Treatments: Gemifloxacin; Insulin; Insulin, Globin Zinc; Moxifloxacin

Criteria

Inclusion Criteria:

• Healthy volunteers having age from 20- 40 years

• Non-Diabetic

• Non-Alcoholics

• Non-Smokers

• Non-Hypertensive

Exclusion Criteria:

• Patients with QT interval prolongation in ECG

• Patients unwilling to give consent

• Patients already on antibiotic therapy for a period one to two week or above.

• Patients who are on other drugs that induces or decreases drug metabolism of quinolones.

• Pregnant female patients.

• Abuse of alcoholic beverages

• Participants who are Allergic or Hypersensitivity to the said drug

• Participants who have participated in a clinical trial within 3 months before the study period.