Bioequivalence Study of Klaribact 125mg/5ml, Suspension (BE)

April 22, 2022 updated by: Dr. Muhammad Raza Shah, University of Karachi

An Open Label, Randomized, Two Way Cross Over, Two Period, Two Treatment, Two Sequence Bioequivalence Study of Klaribact (Clarithromycin) 125mg/5ml Suspension Compared With Klaricid (Clarithromycin) 125mg/5ml Suspension in 24 Healthy Adult Subjects Under Fasting Condition.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Bioequivalence study of Klaribact Suspension will be conducted on 24 healthy participants. Finally selected subjects will be divided into two groups, Group A and Group B, with 12 subjects in each group. The study will be consisted of two periods, Period I and Period II, each comprising of 35 hours, 11 hours before and 24 hours after the drug administration. A washout period of 6 days will be provided between the two periods to ensure the absence of carry over effect. Each group (A & B) will be treated with either of the two sequences, TR or RT, in Period I and the sequence will be inter-changed in Period II. blood samples from each volunteer will be collected at specific time points to analyze plasma concentration of Clarithromycin.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  • Subject who is unable to or likely to be non-compliant with protocol requirements or restrictions.
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Group
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
one single 20 mL dose (500mg) of the test drug will be administered to the volunteers
Active Comparator: Reference Group
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
one single 20 mL dose (500mg) of the Reference drug will be administered to the volunteers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
maximum plasma concentration
Time Frame: up to 24 hours post dose
maximum drug concentration in plasma after dose
up to 24 hours post dose
Time to reach maximum plasma concentration
Time Frame: 0 to 24 hours post dose
Time required for the drug to reach maximum plasma concentration
0 to 24 hours post dose
AUC
Time Frame: 0 to 24hours post dose
Area under the time versus plasma drug concentration curve
0 to 24hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Karachi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck (Pvt.) Limited, Pakistan
Center for Bioequivalence Studies and Clinical Research (CBSCR), HEJ Research Institute of chemistry, University of Karachi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CB-009-CLA-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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