Bioequivalence Study of Klaribact 125mg/5ml, Suspension

NCT05340452 | Completed

• 1 other identifier: CB-009-CLA-2012/Protocol/1.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A two way crossover BE study will be performed to evaluate the comparative bioavailability of Klaribact (Clarithromycin 125 mg/5ml) suspension (Merck Pvt. Ltd, Pakistan) with Klaricid (Clarithromycin 125mg/5ml) suspension (Abbot Laboratories Pakistan Limited) at the clinical site (CBSCR), Karachi Pakistan.

Conditions

Healthy

Keywords

Bioequivalence Study; macrolide antibiotic; Bioavailability comparison

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 to 24hours post dose

Study Arms (2)

Test Group

EXPERIMENTAL

Single oral dose of 20 ml of Test (Klaribact 125mg/5ml Suspension) will be given with the aid of graduated cup.

Drug: Klaribact 125mg/5ml Suspension

Reference Group

ACTIVE COMPARATOR

Single oral dose of 20 ml of Reference (Klaricid 125mg/5ml Suspension) will be given to volunteers with the aid of graduated cup.

Drug: Klaricid 125mg/5ml Suspension

Interventions

Klaribact 125mg/5ml Suspension DRUG

one single 20 mL dose (500mg) of the test drug will be administered to the volunteers

Test Group

Klaricid 125mg/5ml Suspension DRUG

one single 20 mL dose (500mg) of the Reference drug will be administered to the volunteers

Reference 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.
• Participant capable of understanding the informed consent.
• Non Smokers, who have not smoked in last 3 months.
• Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• 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 results 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).
• Subjects with negative urine screen for drugs of abuse. All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical screening procedures and at each study period check-in.
• Subjects having negative alcohol breathe test. All subjects will have breath alcohol test as part of the clinical screening procedures and at each study period check-in.

You may not qualify if:

• Any active allergic disease or a history of any significant allergic disease (e.g. Rhinitis, dermatitis, asthma).
• Known hypersensitivity to Investigational drug(s) or related class of 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 has donated blood (450ml) within 12 weeks minimum preceding the study. 16
• 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.
• Consumption of xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing. or consume juice of grape fruit for within 14 days prior to 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. Drug interaction section at 5.13 should be considered.
• Subjects with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study.
• 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.) Limited, Pakistan: collaborator
• Center for Bioequivalence Studies and Clinical Research (CBSCR), HEJ Research Institute of chemistry, University of Karachi: collaborator

Study Sites (1)

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

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Interventions

Suspensions; Clarithromycin

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Muhammad Shah, PhD

  Center for bio-equivalence studies and clinical research (CBSCR)

  PRINCIPAL INVESTIGATOR

• Naghma R Hashmi, PhD

  Center for bio-equivalence studies and clinical research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An Open Label, Randomized, Two Way Cross Over, Two Period, Two Treatment, Two Sequence Bioequivalence Study

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: June 29, 2013
• Primary Completion: July 8, 2013
• Study Completion: October 25, 2013
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)