HealthyBENCT05340452
Bioequivalence Study of Klaribact 125mg/5ml, Suspension
A study testing Klaribact 125mg/5ml Suspension and Klaricid 125mg/5ml Suspension in people with Healthy, run by University of Karachi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Klaribact 125mg/5ml Suspension and Klaricid 125mg/5ml Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jun 2013to 25 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS
Karachi, Sindh, 75270
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Klaribact 125mg/5ml Suspension, Klaricid 125mg/5ml Suspension
- Keywords
- Bioequivalence Study, macrolide antibiotic, Bioavailability comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Klaribact 125mg/5ml SuspensionDrug
one single 20 mL dose (500mg) of the test drug will be administered to the volunteers
Klaricid 125mg/5ml SuspensionDrug
one single 20 mL dose (500mg) of the Reference drug will be administered to the volunteers
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Single oral dose of 20 ml of Test (Klaribact 125mg/5ml Suspension) will be given with the aid of graduated cup. Receives: 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. Receives: Drug: Klaricid 125mg/5ml Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma concentration
maximum drug concentration in plasma after dose
Measured: up to 24 hours post dose
Time to reach maximum plasma concentration
Time required for the drug to reach maximum plasma concentration
Measured: 0 to 24 hours post dose
AUC
Area under the time versus plasma drug concentration curve
Measured: 0 to 24hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start29 Jun 2013
- Primary completion8 Jul 2013
- Study completion25 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An Open Label, Randomized, Two Way Cross Over, Two Period, Two Treatment, Two Sequence Bioequivalence Study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Merck (Pvt.) Limited, Pakistan, Center for Bioequivalence Studies and Clinical Research
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
- Investigators
- Muhammad Shah, PhD, Principal investigator, Center for bio-equivalence studies and clinical research (CBSCR)Naghma R Hashmi, PhD, Principal investigator, Center for bio-equivalence studies and clinical research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340452
- Sponsor's protocol ID
- CB-009-CLA-2012/Protocol/1.0
- Acronym
- BE
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will only be available to other researchers upon reasonable request to PI keeping the participants' confidentiality intact.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05340452
- Acronym / sponsor ID
- BE / CB-009-CLA-2012/Protocol/1.0
- Conditions
- Healthy
- Keywords
- Bioequivalence Study, macrolide antibiotic, Bioavailability comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Merck (Pvt.) Limited, Pakistan, Center for Bioequivalence Studies and Clinical Research
- Study start
- 29 Jun 2013 (actual)
- Primary completion
- 8 Jul 2013 (actual)
- Study completion
- 25 Oct 2013 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An Open Label, Randomized, Two Way Cross Over, Two Period, Two Treatment, Two Sequence Bioequivalence Study
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Klaribact 125mg/5ml SuspensionSingle oral dose of 20 ml of Test (Klaribact 125mg/5ml Suspension) will be given with the aid of graduated cup. |
| Reference Group | Active comparator | Drug: Klaricid 125mg/5ml SuspensionSingle oral dose of 20 ml of Reference (Klaricid 125mg/5ml Suspension) will be given to volunteers with the aid of graduated cup. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Klaribact 125mg/5ml Suspensionone single 20 mL dose (500mg) of the test drug will be administered to the volunteers | Drug | Test Group |
| Klaricid 125mg/5ml Suspensionone single 20 mL dose (500mg) of the Reference drug will be administered to the volunteers | Drug | Reference Group |
Primary outcome
maximum plasma concentration
Time frame: up to 24 hours post dose
maximum drug concentration in plasma after 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
AUC
Time frame: 0 to 24hours post dose
Area under the time versus plasma drug concentration curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will only be available to other researchers upon reasonable request to PI keeping the participants' confidentiality intact.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Shah, PhD principal investigator
Center for bio-equivalence studies and clinical research (CBSCR)
Naghma R Hashmi, PhD principal investigator
Center for bio-equivalence studies and clinical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Klaribact 125mg/5ml Suspension and Klaricid 125mg/5ml Suspension in people with Healthy, run by University of Karachi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum plasma concentration (time frame: up to 24 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.