HealthyPhase 1BABENCT05339295
Bioequivalence Study of Levomerc 500 mg Tablets
A Phase 1 study testing Levofloxacin 500mg in people with Healthy and Pharmacokintetics, run by University of Karachi at 1 site in Pakistan.
Trial summary
An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokintetics
- What is being tested?
- Levofloxacin 500mg
- 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
- 11 Jul 2012to 20 Sep 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
- 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.
- 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 result 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).
Who cannot join
- Age and/or BMI out of acceptable range.
- 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).
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- Subject donated blood (450ml) within 12 weeks minimum preceding the study.
- 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.
- 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: Bioequivalence Study of Levomerc (Levofloxacin) 500 mg Tablet With Tavanic (Levofloxacin) 500 mg Tablets
An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting condition.
Read the detailed description
The study will be conducted on 24 healthy subjects. The study will comprise of two Periods, I and II, each consisting of 36 hours, 12 hours before and 24 hour after the drug administration. All 24 subjects divided in group of 12 each. One group treated with the test (T) and other one with reference (R) drug in Period I and after the wash out period, the same received the alternate treatment in Period II.
blood samples will be collected for up to 24 hours post dose in each period for plasma analysis of Levofloxacin.
- Conditions
- Healthy, Pharmacokintetics
- Being tested
- Levofloxacin 500mg
- Keywords
- Bioequivalence Study, Pakistani Population, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin 500mgDrug
Also called Levomerc (Levofloxacin) tablets 500 mg, Tavanic (Levofloxacin) tablets 500 mg
A single dose consisting of one tablet of either test drug (Levomerc 500 mg) or reference drug (Tavanic 500mg) administered to each of the subjects in both Period.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Levomerc (Levofloxacin) tablets 500 mg Receives: Drug: Levofloxacin 500mg |
| Reference Group | Active comparator | Tavanic (Levofloxacin) tablets 500 mg Receives: Drug: Levofloxacin 500mg |
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: 0-2 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start11 Jul 2012
- Primary completion20 Jul 2012
- Study completion20 Sep 2012
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 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 KarachiNaghma Hashmi (Co-PI), PhD, Principal investigator, CBSCR, ICCBS, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339295
- Sponsor's protocol ID
- CB-007-LEV-2012/Protocol/1.0
- Acronym
- BABE
- Status last verified
- Sep 2022
- First submitted
- 14 Apr 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: 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Levomerc (Levofloxacin) 500 mg Tablet With Tavanic (Levofloxacin) 500 mg Tablets
- ClinicalTrials.gov ID
- NCT05339295
- Acronym / sponsor ID
- BABE / CB-007-LEV-2012/Protocol/1.0
- Conditions
- Healthy, Pharmacokintetics
- Keywords
- Bioequivalence Study, Pakistani Population, healthy volunteers
- 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
- 11 Jul 2012 (actual)
- Primary completion
- 20 Jul 2012 (actual)
- Study completion
- 20 Sep 2012 (actual)
- First posted
- 21 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.
An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting condition.
Detailed description
The study will be conducted on 24 healthy subjects. The study will comprise of two Periods, I and II, each consisting of 36 hours, 12 hours before and 24 hour after the drug administration. All 24 subjects divided in group of 12 each. One group treated with the test (T) and other one with reference (R) drug in Period I and after the wash out period, the same received the alternate treatment in Period II.
blood samples will be collected for up to 24 hours post dose in each period for plasma analysis of Levofloxacin.
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 Group | Experimental | Drug: Levofloxacin 500mgLevomerc (Levofloxacin) tablets 500 mg |
| Reference Group | Active comparator | Drug: Levofloxacin 500mgTavanic (Levofloxacin) tablets 500 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 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.
- 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.
Key exclusion criteria (19 listed)
- Age and/or BMI out of acceptable range.
- 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).
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 |
|---|---|---|
| Levofloxacin 500mgAlso: Levomerc (Levofloxacin) tablets 500 mg, Tavanic (Levofloxacin) tablets 500 mgA single dose consisting of one tablet of either test drug (Levomerc 500 mg) or reference drug (Tavanic 500mg) administered to each of the subjects in both Period. | Drug | Reference Group, Test 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: 0-2 4hours
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 7 Sep 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.
Prof. Dr. Muhammad R Shah, PhD principal investigator
CBSCR, ICCBS, University of Karachi
Naghma Hashmi (Co-PI), PhD principal investigator
CBSCR, ICCBS, University of Karachi
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 Levofloxacin 500mg in people with Healthy and Pharmacokintetics, 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 8 inclusion and 19 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 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.