Clinical trial

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

Name

ShaheedBBUSheringalD

Description

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.

Trial arms

Trial start

2021-03-01

Estimated PCD

2021-03-15

Trial end

2021-04-01

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Moxfloxacin Group

Other names:

Blood glucose and serum insulin

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.

Arms:

Gemifloxacin Group

Other names:

Blood glucose and serum insulin

Size

Primary endpoint

Hypoglycemia expected as per case reports and studies

4 weeks

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group for Moxifloxacin having 30 healthy euglycemic volunteers, another group for Gemifloxacin having 30 healthy euglycemic volunteers', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Proper care shall be taken while taking blood samples for checking blood glucose and serum insulin levels as per ICH good clinical practices guidelines.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}

Updated at

2023-04-12

1 organization

2 products

3 indications

Organization

Shaheed Benazir Bhutto University Sheringal Dir Upper

Product

Indication

Indication

Indication

Product