Bioequivalence Study of Levomerc 500 mg Tablets (BABE)

Bioequivalence Study of Levomerc (Levofloxacin) 500 mg Tablet With Tavanic (Levofloxacin) 500 mg Tablets

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Pharmacokintetics
• Intervention / Treatment: Drug: Levofloxacin 500mg

Detailed Description

The study will be conducted on 24 healthy subjects. The study will comprise of two Periods, I and II, each consisting of 36 hours, 12 hours before and 24 hour after the drug administration. All 24 subjects divided in group of 12 each. One group treated with the test (T) and other one with reference (R) drug in Period I and after the wash out period, the same received the alternate treatment in Period II.

blood samples will be collected for up to 24 hours post dose in each period for plasma analysis of Levofloxacin.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75270
      • Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All subjects should be healthy and free from any epidemic, contagious or measurable disease (e.g. Malaria, Dengue).
• Age range for inclusion will be 18-50 year.
• 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).

Exclusion Criteria:

• 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. -
• Participation in other drug studies within three months prior to study initiation.
• Subjects with any physical/mental disability.
• Limited mental capacity to the extent that the subject is unable to provide legal consent and information regarding the side effects or tolerance of the study drug.
• Pregnancy or breast feeding, women of child bearing age who are not using a recognized form of contraception for at least last 30 days or using hormonal contraception, are also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Group; Levomerc (Levofloxacin) tablets 500 mg	Drug: Levofloxacin 500mg; 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.; Other Names: Levomerc (Levofloxacin) tablets 500 mg; Tavanic (Levofloxacin) tablets 500 mg
ACTIVE_COMPARATOR: Reference Group; Tavanic (Levofloxacin) tablets 500 mg	Drug: Levofloxacin 500mg; 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.; Other Names: Levomerc (Levofloxacin) tablets 500 mg; Tavanic (Levofloxacin) tablets 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Karachi
• Collaborators: Merck Pvt. Ltd, Pakistan; Center for bioequivalence studies and clinical reseach (CBSCR), ICCBS, University of Karachi
• Investigators: Principal Investigator: Prof. Dr. Muhammad R Shah, PhD, CBSCR, ICCBS, University of Karachi

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2012
• Primary Completion (ACTUAL): July 20, 2012
• Study Completion (ACTUAL): September 20, 2012

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (ACTUAL): April 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: healthy volunteers; Bioequivalence Study; Pakistani Population
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: CB-007-LEV-2012/Protocol/1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will only be available to other researchers upon reasonable request to PI keeping the participants' confidentiality intact.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No