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

NCT04692623 | Completed Phase 1 DMC

• 1 other identifier: ShaheedBBUSheringalD
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Blood Glucose, Low; Hypoglycemia

Keywords

,Blood glucose,Serum insulin

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia expected as per case reports and studies

  Blood glucose level monitoring

  4 weeks

Study Arms (2)

Moxfloxacin Group

EXPERIMENTAL

In this arm 30 healthy volunteers were selected and they were given Moxifloxacin drug.

Drug: Moxifloxacin 400mg

Gemifloxacin Group

EXPERIMENTAL

In this arm 30 healthy volunteers were selected and they were given Gemifloxacin

Drug: Gemifloxacin 320 MG

Interventions

Moxifloxacin 400mg DRUG

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.

Also known as: Blood glucose and serum insulin

Moxfloxacin Group

Gemifloxacin 320 MG DRUG

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.

Also known as: Blood glucose and serum insulin

Gemifloxacin Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Both male and female healthy euglycemic volunteers are eligible for inclusion in the studies
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers having age from 20- 40 years
• Non-Diabetic
• Non-Alcoholics
• Non-Smokers
• Non-Hypertensive

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Benazir Bhutto University Sheringal Dir Upper: lead
• Khyber Medical University Peshawar: collaborator

Study Sites (1)

Khyber Medical University,Peshawar

Peshawar, Khyber Pukhtan Khawa, 091, Pakistan

Location

Related Publications (2)

• Zimmet P. Globalization, coca-colonization and the chronic disease epidemic: can the Doomsday scenario be averted? J Intern Med. 2000 Mar;247(3):301-10. doi: 10.1046/j.1365-2796.2000.00625.x.

  PMID: 10762445 BACKGROUND

• Ullah A, Ahmad S, Ali N, Rahman SU, Hussain H, Alghamdi S, Almehmadi M, Dablool AS, Bannunah AM, Bukhari SH, Almarshad F. Insulinotropic Potential of Moxifloxacin and Gemifloxacin: An In Vivo Rabbits Model Study Followed by Randomized Phase I Clinical Trial. Antibiotics (Basel). 2022 Jan 24;11(2):148. doi: 10.3390/antibiotics11020148.

  PMID: 35203750 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Interventions

Moxifloxacin; Blood Glucose; Gemifloxacin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Naphthyridines

Study Officials

• Abid Ullah, Ph.D Scholar

  Departemt of Pharmacy,Shaheed Benazir Bhutto University,Sheringal Dir Upper,KP,Pakistan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Proper care shall be taken while taking blood samples for checking blood glucose and serum insulin levels as per ICH good clinical practices guidelines.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pharmacy,SBBU,Sheringal Dir Upper

Model Details: Single group for Moxifloxacin having 30 healthy euglycemic volunteers, another group for Gemifloxacin having 30 healthy euglycemic volunteers

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: March 1, 2021
• Primary Completion: March 15, 2021
• Study Completion: April 1, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: one month for complete data cllection and compilation
• Access Criteria: At the official website of Shaheed Benazir Bhutto University sheringal Dir upper

Locations

PA (1)