Bioequivalence Study of Levomerc 500 mg Tablets

NCT05339295 | Completed Phase 1

• 1 other identifier: CB-007-LEV-2012/Protocol/1.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting condition.

Conditions

Healthy; Pharmacokintetics

Keywords

Bioequivalence Study; Pakistani Population; healthy volunteers

Outcome Measures

Primary Outcomes (3)

• maximum plasma concentration

  maximum drug concentration in plasma after dose

  up to 24 hours post dose

• Time to reach maximum plasma concentration

  Time required for the drug to reach maximum plasma concentration

  0 to 24 hours post dose

• AUC

  Area under the time versus plasma drug concentration curve

  0-2 4hours

Study Arms (2)

Test Group

EXPERIMENTAL

Levomerc (Levofloxacin) tablets 500 mg

Drug: Levofloxacin 500mg

Reference Group

ACTIVE COMPARATOR

Tavanic (Levofloxacin) tablets 500 mg

Drug: Levofloxacin 500mg

Interventions

Levofloxacin 500mg DRUG

A single dose consisting of one tablet of either test drug (Levomerc 500 mg) or reference drug (Tavanic 500mg) administered to each of the subjects in both Period.

Also known as: Levomerc (Levofloxacin) tablets 500 mg, Tavanic (Levofloxacin) tablets 500 mg

Reference Group; Test Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects should be healthy and free from any epidemic, contagious or measurable disease (e.g. Malaria, Dengue).
• BMI for all Subjects will be between 18.5-26.9 kg/ m2.
• Non Smokers, who have not smoked in last 3 months.
• Medical history, physical examination and screening tests must fall in normal range, unless the investigator considers the abnormality to be clinically not significant.
• Clinical laboratory test result should be within a normal range.
• Participants (who can read and understand Urdu) should be able to give informed consent, understand and sign the Informed Consent Form.
• Participants should have adequate organ function (i.e., kidney, liver and heart).

You may not qualify if:

• Age and/or BMI out of acceptable range.
• Any active allergic disease or a history of any significant allergic disease (e.g. Rhinitis, dermatitis, asthma).
• Known hypersensitivity to Investigational drug(s).
• Abnormal results of blood and urine tests conducted at screening unless the investigator considers an abnormality to be clinically irrelevant.
• Presence or history of cardiac (e.g. Myocardial Infarction, arrythmia), renal (e.g. renal insufficiency) , hepatic (e.g. hepatic impairment) , organ insufficiency, bone marrow disease, hematological abnormality (e.g. leukemia, anemia), photosensitivity, neurological disorders (e.g. Alzheimer's disease) or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination (e.g. dysphagia).
• History or presence of any musculo skeletal disease (e.g. Tendonitis).
• Subject donated blood (450ml) within 12 weeks minimum preceding the study.
• Alcoholic or with a history of chronic alcohol intake or consumed alcohol or Gutka in last 3 months.
• Ingestion of OTC drug, within 14 days of drug administration (e.g. aspirin, ibuprofen).
• History of intake of any prescribed medicine (e.g. captopril, sumatriptan) during a period of 30 days, prior to drug administration day of study.
• Ingestion of investigational drug within 30 days, prior to investigational drug administration in the study.
• Ingestion of any known hepatic or renal clearance altering agents (e.g. erythromycin, cimetidine, barbiturates, phenothiazines, etc.) for a period of 30 days, prior to study initiation.
• Subjects with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study.
• xiv. Subjects with known HIV, hepatitis B or C infection or autoimmune diseases.
• History of drug exposure which, in the opinion of Investigator, amounts to drug abuse. -

Sponsors & Collaborators

• University of Karachi: lead
• Merck Pvt. Ltd, Pakistan: collaborator
• Center for bioequivalence studies and clinical reseach (CBSCR), ICCBS, University of Karachi: collaborator

Study Sites (1)

Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Interventions

Levofloxacin; Tablets; Ofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Prof. Dr. Muhammad R Shah, PhD

  CBSCR, ICCBS, University of Karachi

  PRINCIPAL INVESTIGATOR

• Naghma Hashmi (Co-PI), PhD

  CBSCR, ICCBS, University of Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A single center, open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: July 11, 2012
• Primary Completion: July 20, 2012
• Study Completion: September 20, 2012
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)