Bioequivalence Study of Klaribact (Clarithromycin) 500 mg, Film Coated Tablet

NCT05436769 | Completed Phase 1

• 1 other identifier: CB-006-CLA-2012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is An Open Label, Randomized, Single Dose, Two Way Cross over, Two Period, Two Treatment, Two Sequence Bioequivalence Study to compare the rate and extent of absorption of Klaribact FC Tablet (Clarithromycin 500 mg) with Reference Product, Klaricid FC Tablet (Clarithromycin 500 mg) in healthy adult male subjects under fasting condition.

Conditions

Healthy Volunteers; Bioequivalence Study

Keywords

Bioequivalence Study; Clarithromycin Tablet

Outcome Measures

Primary Outcomes (3)

• maximum plasma drug concentration

  maximum drug concentration in plasma after dosing

  up to 24 hours post dose

• AUC last (AUC 0-t)

  Area under plasma concentration time curve from zero to time of the last measurable concentration

  0 to 24 hours post dose

• AUC total (AUC 0-∞)

  area under the plasma concentration-time curve from zero to infinity.

  0 to 24 hours post dose

Secondary Outcomes (1)

• Time to reach maximum plasma concentration

  up to 24 hours post dose

Study Arms (2)

Test Drug

EXPERIMENTAL

Klaribact (Clarithromycin 500 mg) Film Coated Tablet (Merck Pvt. Ltd, Pakistan)

Drug: Klaribact 500 mg Clarithromycin Tablet; Drug: Klaricid 500 mg Clarithromycin Tablet

Reference Drug

ACTIVE COMPARATOR

Klaricid 500 mg (Clarithromycin 500 mg) Film Coated Tablet (Abbot Laboratories (Pakistan) Limited)

Drug: Klaribact 500 mg Clarithromycin Tablet; Drug: Klaricid 500 mg Clarithromycin Tablet

Interventions

Klaribact 500 mg Clarithromycin Tablet DRUG

A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.

Reference Drug; Test Drug

Klaricid 500 mg Clarithromycin Tablet DRUG

A single dose consisting of one Tablet of either test drug (Klaribact 500 mg) or reference drug (Klaricid 500mg) administered to each of the subjects in fasting condition with 240 mL water in both Periods alternatively.

Reference Drug; Test Drug

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• 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.
• 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.

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).
• 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. 19
• 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. Drug interaction section at 5.12 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.
• Participation in other drug studies within three months prior to study initiation.

Sponsors & Collaborators

• University of Karachi: lead
• Merck Pvt. Ltd, Pakistan: collaborator
• Center for Bioequivalence Studies and Clinical Research: collaborator

Study Sites (1)

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

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Interventions

Clarithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Prof. Dr. Muhammad R Shah, PhD

  CBSCR, ICCBS, University of Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

• Dr. Naghma Hashmi (Co-PI), PhD

  CBSCR, ICCBS, University of Karachi, Pakistan

  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: June 23, 2022
• First Posted: June 29, 2022
• Study Start: October 23, 2012
• Primary Completion: November 2, 2012
• Study Completion: December 25, 2012
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)