BioequivalencePhase 1NCT05307614
Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani Subjects
A Phase 1 study testing Moksi® 400mg Tablet and Drug: Avelox® 400Mg Tablet in people with Bioequivalence, run by Abbott at 1 site in Pakistan.
Trial summary
Single dose, two way crossover Bioequivalence (BE) study to evaluate the comparative bioavailability of moxifloxacin. 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
- Bioequivalence
- What is being tested?
- Moksi® 400mg Tablet and Drug: Avelox® 400Mg Tablet
- 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
- 27 Mar 2019to 27 Apr 2019
- 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 male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination,including vital sign monitoring (ie, blood pressure, heart rate,and temperature), 12 lead ECG ,chest X ray and laboratory analysis (ie, hematology, blood biochemistry and urinalysis), as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (Opiates, benzodiazepines, amphetamines, barbiturates, cannabinoids and cocaine will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects and their partners are willing to use reliable non-hormonal contraceptive methods (condoms, diaphragm, non-hormonal intra- uterine device (IUD), female or male sterilization or sexual abstinence) throughout the study and up to 30 days after the last administration of the study drug
- All subjects should be free from any epidemic or contagious diseases (e.g. Malaria, Dengue).
- Subjects will be 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.
Who cannot join
- History of smoking (> 5 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/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.
- Subject is allergic to Moxifloxacin and/or other fluoroquinolones
- Subject has received any investigational drug within four weeks.
- Subjects with known prolongation of the QT interval.
- Subjects receiving Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic agents.
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- Subjects with salt imbalance in the blood (especially low levels of potassium or magnesium in the blood)
- Subject taking any vitamins or herbal supplements during within last 14 days of drug administration.
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- Ingestion of OTC drug, within 7 days of drug administration (e.g. aspirin, ibuprofen).
- History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study.
- History of any significant illness in the last four weeks
- Subjects who smoke and/or take nicotine in any form. Non-smoking subjects, who have previously smoked, should at least be non-smoking for 6 months prior to dosing.
- Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, verapamil and dronedarone.
- Consumption of grapefruit and/or its products within 14 days prior to the start of study.
- Subjects who test positive for syphilis (VDRL)or who are known to have serum hepatitis or who are carriers 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)
- Individuals having undergone any major surgery within 3 months prior to the start of the study,
- Subject has a history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating moxifloxacin to the subject.
- Inability to take oral medication.
- Subjects with any condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs.
- Subjects with clinically significant abnormalities in investigations (safety assessments) as determined by the Investigator
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and Clinical Research (CBSCR) ICCBS, University of Karachi
Karachi, Sindh, 75270
About this study
Official title: A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Relative Bioavailability of Moksi 400mg (Moxifloxacin) Tablet and Avelox 400mg (Moxifloxacin) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
Single dose, two way crossover Bioequivalence (BE) study to evaluate the comparative bioavailability of moxifloxacin.
Read the detailed description
A single center, single-dose, open-label randomized , 2-way crossover Bioequivalence study in healthy Pakistani subjects. Study drugs, Moksi® 400 mg (Moxifloxacin) Tablet manufactured by Abbot Laboratories (Pakistan) Limited and Avelox® 400mg (Moxifloxacin) Tablet manufactured by Bayer HealthCare Pharmaceuticals Inc were administered in two periods separated by a washout period of seven (07) days. After dosing, serial blood samples were collected for a period of 72.0 hours.
- Conditions
- Bioequivalence
- Being tested
- Moksi® 400mg Tablet, Drug: Avelox® 400Mg Tablet
- Keywords
- Moxifloxacin, Fluoroquinolone, Bioequivalence, Pakistani population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moksi® 400mg TabletDrug
Also called Moksi®
Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.
Drug: Avelox® 400Mg TabletDrug
Also called Avelox®
Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Moksi® 400mg Tablet of Abbott | Experimental | Healthy subjects were orally administered a single dose of Moksi® 400mg Tablet (Moxifloxacin) under fasting condition Receives: Drug: Moksi® 400mg Tablet; Drug: Drug: Avelox® 400Mg Tablet |
| Avelox® 400mg Tablet of Bayer | Active comparator | Healthy subjects were orally administered a single dose of Avelox® 400mg Tablet (Moxifloxacin) under fasting condition. Receives: Drug: Moksi® 400mg Tablet; Drug: Drug: Avelox® 400Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum plasma concentration of Moxifloxacin
Measured: 0-72 hours post dose
AUC last (AUC 0-t)
Area under plasma concentration time curve from zero to time of the last measurable concentration
Measured: 0-72 hours post dose
AUC total (AUC 0-∞)
area under the plasma concentration-time curve from zero to infinity.
Measured: 0-72 hours post dose
Secondary outcomes (1)
Tmax
time to reach maximum plasma concentration
Measured: 0-72 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 posted1 Apr 2022
- Study start27 Mar 2019
- Primary completion23 Apr 2019
- Study completion27 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross Over
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raeefuddin Ahmed, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307614
- Sponsor's protocol ID
- MOXI1001
- Other IDs
- CB-023-MOX-2017/Protocol/2.0
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Relative Bioavailability of Moksi 400mg (Moxifloxacin) Tablet and Avelox 400mg (Moxifloxacin) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
- ClinicalTrials.gov ID
- NCT05307614
- Acronym / sponsor ID
- MOXI1001
- Conditions
- Bioequivalence
- Keywords
- Moxifloxacin, Fluoroquinolone, Bioequivalence, Pakistani population
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 27 Apr 2019 (actual)
- First posted
- 1 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.
Single dose, two way crossover Bioequivalence (BE) study to evaluate the comparative bioavailability of moxifloxacin.
Detailed description
A single center, single-dose, open-label randomized , 2-way crossover Bioequivalence study in healthy Pakistani subjects. Study drugs, Moksi® 400 mg (Moxifloxacin) Tablet manufactured by Abbot Laboratories (Pakistan) Limited and Avelox® 400mg (Moxifloxacin) Tablet manufactured by Bayer HealthCare Pharmaceuticals Inc were administered in two periods separated by a washout period of seven (07) days. After dosing, serial blood samples were collected for a period of 72.0 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross Over
| Arm | Type | Receives |
|---|---|---|
| Moksi® 400mg Tablet of Abbott | Experimental | Drug: Moksi® 400mg Tablet, Drug: Drug: Avelox® 400Mg TabletHealthy subjects were orally administered a single dose of Moksi® 400mg Tablet (Moxifloxacin) under fasting condition |
| Avelox® 400mg Tablet of Bayer | Active comparator | Drug: Moksi® 400mg Tablet, Drug: Drug: Avelox® 400Mg TabletHealthy subjects were orally administered a single dose of Avelox® 400mg Tablet (Moxifloxacin) under fasting condition. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination,including vital sign monitoring (ie, blood pressure, heart rate,and temperature), 12 lead ECG ,chest X ray and laboratory analysis (ie, hematology, blood biochemistry and urinalysis), as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (Opiates, benzodiazepines, amphetamines, barbiturates, cannabinoids and cocaine will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects and their partners are willing to use reliable non-hormonal contraceptive methods (condoms, diaphragm, non-hormonal intra- uterine device (IUD), female or male sterilization or sexual abstinence) throughout the study and up to 30 days after the last administration of the study drug
Key exclusion criteria (21 listed)
- History of smoking (> 5 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/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.
- Subject is allergic to Moxifloxacin and/or other fluoroquinolones
- Subject has received any investigational drug within four weeks.
- Subjects with known prolongation of the QT interval.
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 |
|---|---|---|
| Moksi® 400mg TabletAlso: Moksi®Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast. | Drug | Avelox® 400mg Tablet of Bayer, Moksi® 400mg Tablet of Abbott |
| Drug: Avelox® 400Mg TabletAlso: Avelox®Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast. | Drug | Avelox® 400mg Tablet of Bayer, Moksi® 400mg Tablet of Abbott |
Primary outcome
Cmax
Time frame: 0-72 hours post dose
maximum plasma concentration of Moxifloxacin
AUC last (AUC 0-t)
Time frame: 0-72 hours post dose
Area under plasma concentration time curve from zero to time of the last measurable concentration
AUC total (AUC 0-∞)
Time frame: 0-72 hours post dose
area under the plasma concentration-time curve from zero to infinity.
1 secondary outcome
Tmax
Time frame: 0-72 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 1 Apr 2022.
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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.
Raeefuddin Ahmed, MD study director
Abbott
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 Moksi® 400mg Tablet and Drug: Avelox® 400Mg Tablet in people with Bioequivalence, run by Abbott 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 7 inclusion and 21 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 1 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.
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?
Cmax (time frame: 0-72 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 1 Apr 2022.