Healthy IndividualsPhase 1BENCT04873570
Bioequivalence Study of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects
A Phase 1 study testing Moxifloxacin 400mg in people with Healthy Individuals and Bioequivalence Study, run by University of Karachi at 1 site in Pakistan.
Trial summary
Single oral dose, of test and reference Tablet will be administered to healthy volunteers, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Bioequivalence Study
- What is being tested?
- Moxifloxacin 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 28 May 2021to 10 Jun 2021
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18 to 55 years inclusive.
- Subjects with a body mass index (BMI) from 18.5 to 30 kg/m2.
- Subject is able to fast for 14 hours and consume standard meals.
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-Lead ECG, and safety laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis) or viral serology as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (morphine \& cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects who are able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
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- Subject agreed not to consume food or beverages including dairy products, tea, coffee, cola drinks, chocolates containing xanthine derivatives (including caffeine, theobromines, etc.) and/or poppy seeds (Khash khash) within 48 hours prior to drug administration until last blood draw in each study period.
- Subject agreed not to intake prescription drugs (especially amiodarone, carbamazepine, Antacids (aluminum and magnesium hydroxides) NSAIDS, digoxin and Blood thinners such as warfarin, etc.) within 14 days or 5 half-lives (whichever is longer) prior to first dose of study medicine.
- Subject agreed not to intake non-prescription drugs (OTC) within 14 days prior to first dose of study medicine.
- Subject agreed to discontinue vitamins, dietary and herbal supplements within 14 days prior to the first dose of study medication.
- Subject agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.
Who cannot join
- Subjects who refused to sign Informed Consent Form.
- Subject not able to take medicine orally.
- Pregnant and lactating females.
- History of smoking ≥3 cigarette/day, alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subject has clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subjects known to be allergic to Moxifloxacin and/or other Quinolones antibiotics
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- Subject who has received any other investigational drug within four weeks.
- Subject who has participated in any other clinical trials within 3 months.
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- History of any significant illness in the last four weeks which might confound in the result of the study or post additional risk in administrating Moxifloxacin to the subject.
- Subjects tested positive for syphilis (VDRL) or is known to have serum hepatitis or carrier of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and clinical research
Karachi, Sindh, 75270
About this study
Official title: A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects.
Single oral dose, of test and reference Tablet will be administered to healthy volunteers, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose.
- Conditions
- Healthy Individuals, Bioequivalence Study
- Being tested
- Moxifloxacin 400mg
- Keywords
- Fluoroquinolone, Moxifloxacin, Bioequivalence, Pakistani Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin 400mgDrug
Moxifloxacin 400mg IR tablet
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Subjects will be given one Mofest® 400mg (Moxifloxacin HCl) Tablet (1x400mg) manufactured by SAMI Pharmaceuticals (Pvt.) after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose. Receives: Drug: Moxifloxacin 400mg |
| Reference Group | Active comparator | Subjects will be given one Avelox® 400mg (Moxifloxacin HCl) Tablet (1x400mg), manufactured by Bayer HealthCare, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose. Receives: Drug: Moxifloxacin 400mg |
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 72 hours post dose
Time to reach maximum plasma concentration
Time required for the drug to reach maximum plasma concentration
Measured: 0 to 72 hours post dose
AUC
Area under the time versus plasma drug concentration curve
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start28 May 2021
- Primary completion8 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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, single-dose, two-period, two-way cross-over study
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- SAMI Pharmaceuticals (Pvt.) Ltd., 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
- NCT04873570
- Sponsor's protocol ID
- CB-034-MOX(M)-2020
- Acronym
- BE
- Status last verified
- Sep 2022
- First submitted
- 28 Apr 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects.
- ClinicalTrials.gov ID
- NCT04873570
- Acronym / sponsor ID
- BE / CB-034-MOX(M)-2020
- Conditions
- Healthy Individuals, Bioequivalence Study
- Keywords
- Fluoroquinolone, Moxifloxacin, Bioequivalence, Pakistani Population
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- SAMI Pharmaceuticals (Pvt.) Ltd., Center for Bioequivalence Studies and Clinical Research
- Study start
- 28 May 2021 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 5 May 2021 (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.
Single oral dose, of test and reference Tablet will be administered to healthy volunteers, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose.
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, single-dose, two-period, two-way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Moxifloxacin 400mgSubjects will be given one Mofest® 400mg (Moxifloxacin HCl) Tablet (1x400mg) manufactured by SAMI Pharmaceuticals (Pvt.) after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose. |
| Reference Group | Active comparator | Drug: Moxifloxacin 400mgSubjects will be given one Avelox® 400mg (Moxifloxacin HCl) Tablet (1x400mg), manufactured by Bayer HealthCare, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy subjects aged 18 to 55 years inclusive.
- Subjects with a body mass index (BMI) from 18.5 to 30 kg/m2.
- Subject is able to fast for 14 hours and consume standard meals.
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-Lead ECG, and safety laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis) or viral serology as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (morphine \& cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
Key exclusion criteria (11 listed)
- Subjects who refused to sign Informed Consent Form.
- Subject not able to take medicine orally.
- Pregnant and lactating females.
- History of smoking ≥3 cigarette/day, alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subject has clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
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 |
|---|---|---|
| Moxifloxacin 400mgMoxifloxacin 400mg IR tablet | Drug | Reference Group, Test Group |
Primary outcome
maximum plasma concentration
Time frame: up to 72 hours post dose
maximum drug concentration in plasma after dose
Time to reach maximum plasma concentration
Time frame: 0 to 72 hours post dose
Time required for the drug to reach maximum plasma concentration
AUC
Time frame: 0-72 hours
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, 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 Moxifloxacin 400mg in people with Healthy Individuals 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 11 inclusion and 11 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 72 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.