Healthy VolunteersPhase 1BENCT05436769
Bioequivalence Study of Klaribact (Clarithromycin) 500 mg, Film Coated Tablet
A Phase 1 study testing Klaribact 500 mg Clarithromycin Tablet and Klaricid 500 mg Clarithromycin Tablet in people with Healthy Volunteers and Bioequivalence Study, run by University of Karachi at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Bioequivalence Study
- What is being tested?
- Klaribact 500 mg Clarithromycin Tablet and Klaricid 500 mg Clarithromycin Tablet
- 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
- 23 Oct 2012to 25 Dec 2012
- Phase
- Phase 1
- 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
- Men only
- 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.
- Medical history, physical examination and screening tests must fall in normal range, unless the investigator considers the abnormality to be clinically not significant.
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- 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.
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).
- 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
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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.
- 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.
- 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.
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, Single Dose, Two-way Crossover , Two-Period, Two-Treatment, Two-Sequence Bioequivalence Study of Klaribact Tablet (Clarithromycin 500 mg), Compared With Reference Product, Klaricid Tablet (Clarithromycin 500 mg) in Healthy Adult Male Subjects
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.
Read the detailed description
The study will be conducted on 24 healthy adult male subjects in two Periods i.e. period I and II. The study subjects will stay at the clinical trial site for 35 hours, 11 hours before and 24 hours after the drug administration. All 24 subjects will be divided in two groups of 12 subjects in each group. One group will be treated with the test drug (T) and the other one with reference drug (R) in Period I. After the wash-out period of 7 days, the volunteers in these groups will receive the alternate treatment sequence (RT) in Period II.
Blood samples will be collected at 0 hr (before drug administration) 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 16 and 24 hours after drug administration for quantification of Clarithromycin in plasma through LCMS/MS validated method.
- Conditions
- Healthy Volunteers, Bioequivalence Study
- Being tested
- Klaribact 500 mg Clarithromycin Tablet, Klaricid 500 mg Clarithromycin Tablet
- Keywords
- Bioequivalence Study, Clarithromycin Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Klaribact 500 mg Clarithromycin TabletDrug
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.
Klaricid 500 mg Clarithromycin TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | Klaribact (Clarithromycin 500 mg) Film Coated Tablet (Merck Pvt. Ltd, Pakistan) Receives: 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) Receives: Drug: Klaribact 500 mg Clarithromycin Tablet; Drug: Klaricid 500 mg Clarithromycin Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma drug concentration
maximum drug concentration in plasma after dosing
Measured: 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
Measured: 0 to 24 hours post dose
AUC total (AUC 0-∞)
area under the plasma concentration-time curve from zero to infinity.
Measured: 0 to 24 hours post dose
Secondary outcomes (1)
Time to reach maximum plasma concentration
Time required for the drug to reach maximum plasma concentration
Measured: up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start23 Oct 2012
- Primary completion2 Nov 2012
- Study completion25 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A single center, 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. Ltd, Pakistan, Center for Bioequivalence Studies and Clinical Research
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
- Investigators
- Prof. Dr. Muhammad R Shah, PhD, Principal investigator, CBSCR, ICCBS, University of Karachi, PakistanDr. Naghma Hashmi (Co-PI), PhD, Principal investigator, CBSCR, ICCBS, University of Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436769
- Sponsor's protocol ID
- CB-006-CLA-2012
- Acronym
- BE
- Status last verified
- Sep 2022
- First submitted
- 23 Jun 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Un-identified individual participant data (IPD) will be available to other researchers on reasonable request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, Two-way Crossover , Two-Period, Two-Treatment, Two-Sequence Bioequivalence Study of Klaribact Tablet (Clarithromycin 500 mg), Compared With Reference Product, Klaricid Tablet (Clarithromycin 500 mg) in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT05436769
- Acronym / sponsor ID
- BE / CB-006-CLA-2012
- Conditions
- Healthy Volunteers, Bioequivalence Study
- Keywords
- Bioequivalence Study, Clarithromycin Tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Merck Pvt. Ltd, Pakistan, Center for Bioequivalence Studies and Clinical Research
- Study start
- 23 Oct 2012 (actual)
- Primary completion
- 2 Nov 2012 (actual)
- Study completion
- 25 Dec 2012 (actual)
- First posted
- 29 Jun 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.
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.
Detailed description
The study will be conducted on 24 healthy adult male subjects in two Periods i.e. period I and II. The study subjects will stay at the clinical trial site for 35 hours, 11 hours before and 24 hours after the drug administration. All 24 subjects will be divided in two groups of 12 subjects in each group. One group will be treated with the test drug (T) and the other one with reference drug (R) in Period I. After the wash-out period of 7 days, the volunteers in these groups will receive the alternate treatment sequence (RT) in Period II.
Blood samples will be collected at 0 hr (before drug administration) 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 16 and 24 hours after drug administration for quantification of Clarithromycin in plasma through LCMS/MS validated method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single center, open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: Klaribact 500 mg Clarithromycin Tablet, Drug: Klaricid 500 mg Clarithromycin TabletKlaribact (Clarithromycin 500 mg) Film Coated Tablet (Merck Pvt. Ltd, Pakistan) |
| Reference Drug | Active comparator | Drug: Klaribact 500 mg Clarithromycin Tablet, Drug: Klaricid 500 mg Clarithromycin TabletKlaricid 500 mg (Clarithromycin 500 mg) Film Coated Tablet (Abbot Laboratories (Pakistan) Limited) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 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 (18 listed)
- 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).
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 500 mg Clarithromycin TabletA 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. | Drug | Reference Drug, Test Drug |
| Klaricid 500 mg Clarithromycin TabletA 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. | Drug | Reference Drug, Test Drug |
Primary outcome
maximum plasma drug concentration
Time frame: up to 24 hours post dose
maximum drug concentration in plasma after dosing
AUC last (AUC 0-t)
Time frame: 0 to 24 hours post dose
Area under plasma concentration time curve from zero to time of the last measurable concentration
AUC total (AUC 0-∞)
Time frame: 0 to 24 hours post dose
area under the plasma concentration-time curve from zero to infinity.
1 secondary outcome
Time to reach maximum plasma concentration
Time frame: up to 24 hours post dose
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 7 Sep 2022.
- Individual participant dataSharing planned: No. Un-identified individual participant data (IPD) will be available to other researchers on reasonable request to the principal investigator
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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.
Prof. Dr. Muhammad R Shah, PhD principal investigator
CBSCR, ICCBS, University of Karachi, Pakistan
Dr. Naghma Hashmi (Co-PI), PhD principal investigator
CBSCR, ICCBS, University of Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Klaribact 500 mg Clarithromycin Tablet and Klaricid 500 mg Clarithromycin Tablet in people with Healthy Volunteers and Bioequivalence Study, 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 10 inclusion and 18 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 7 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 drug 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 7 Sep 2022.