HealthyPhase 1NCT02322619
Bio-equivalency Study of Moxifloxacin Tablets, 400 mg Under Fasting Conditions
A Phase 1 study testing Moxifloxacin Tablets 400 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in human subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Moxifloxacin Tablets 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult human volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having a Body Mass Index (BMI) between 18.5 to 24.9 (both inclusive), calculated as weight in kg / height in m2.
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
- In case of female subjects:
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- Surgically sterilized at least 6 months prior to study participation or
- If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. and
- Pregnancy test must be negative.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Moxifloxacin, other Quinolones or any of the excipients or any related drug.
- History or presence of any disease or disorder known to influence bone metabolism, compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of medicine [including vitamin, herbal supplements and any enzyme modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes and strong inducers of CYP enzymes] at any time within 14 days prior to check in of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- If the QTc interval will be more than 450 ms on ECG measurement at the time of screening.
- Any history or presence of hypokalamia, QT prolongation including torsades de pointe.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
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- A recent history of harmful use of alcohol(less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to check in.
- Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
- History or presence of psychiatric disorders.
- A history of difficulty with donating blood.
- Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the first dose of study medicine.
- Note: In case the blood loss was less than or equal to 200 mL; subject may be enrolled 60 days after blood donation or after the last sample of previous study
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- A positive test result for HIV antibody.
- Consumption of grape fruit or grape fruit products within 48 hours prior to check in.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to check in of Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Nursing mothers (females).
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Moxifloxacin Tablets, 400 mg of Dr. Reddy's Laboratories Limited, Comparing With Avelox® Tablets 400 mg of Bayer Healthcare Pharmaceuticals Inc. in Healthy, Adult Human Subjects Under Fasting Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in human subjects under fasting conditions.
Read the detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of moxifloxacin tablets 400 mg of Dr. Reddy's Laboratories Limited, comparing with Avelox ® Tablets 400 mg of Bayer Healthcare Pharmaceuticals Inc. in healthy, adult, human subjects under fasting conditions.
- Conditions
- Healthy
- Being tested
- Moxifloxacin Tablets 400 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin Tablets 400 mgDrug
Also called Avelox
Moxifloxacin Tablets 400 mg of Dr. Reddy's Laboratories Limited
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin Tablets 400 mg | Experimental | Moxifloxacin Tablets 400 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Moxifloxacin Tablets 400 mg |
| Avelox Tablets 400 mg | Active comparator | Avelox® Tablets 400 mg of Bayer Healthcare Pharmaceuticals Inc. Receives: Drug: Moxifloxacin Tablets 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve
Measured: 0.167, 0.333, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000 and 48.000 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Shashikanth Sharma, MD, Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322619
- Sponsor's protocol ID
- 054-12
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Moxifloxacin Tablets, 400 mg of Dr. Reddy's Laboratories Limited, Comparing With Avelox® Tablets 400 mg of Bayer Healthcare Pharmaceuticals Inc. in Healthy, Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT02322619
- Acronym / sponsor ID
- 054-12
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in human subjects under fasting conditions.
Detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of moxifloxacin tablets 400 mg of Dr. Reddy's Laboratories Limited, comparing with Avelox ® Tablets 400 mg of Bayer Healthcare Pharmaceuticals Inc. in healthy, adult, human subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin Tablets 400 mg | Experimental | Drug: Moxifloxacin Tablets 400 mgMoxifloxacin Tablets 400 mg of Dr. Reddy's Laboratories Limited |
| Avelox Tablets 400 mg | Active comparator | Drug: Moxifloxacin Tablets 400 mgAvelox® Tablets 400 mg of Bayer Healthcare Pharmaceuticals Inc. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult human volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having a Body Mass Index (BMI) between 18.5 to 24.9 (both inclusive), calculated as weight in kg / height in m2.
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
Key exclusion criteria (19 listed)
- Known hypersensitivity or idiosyncratic reaction to Moxifloxacin, other Quinolones or any of the excipients or any related drug.
- History or presence of any disease or disorder known to influence bone metabolism, compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of medicine [including vitamin, herbal supplements and any enzyme modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes and strong inducers of CYP enzymes] at any time within 14 days prior to check in of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
- If the QTc interval will be more than 450 ms on ECG measurement at the time of screening.
- Any history or presence of hypokalamia, QT prolongation including torsades de pointe.
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 Tablets 400 mgAlso: AveloxMoxifloxacin Tablets 400 mg of Dr. Reddy's Laboratories Limited | Drug | Avelox Tablets 400 mg, Moxifloxacin Tablets 400 mg |
Primary outcome
Area under curve
Time frame: 0.167, 0.333, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000 and 48.000 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 23 Dec 2014.
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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.
Dr. Shashikanth Sharma, MD principal investigator
Lambda Therapeutic Research Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin Tablets 400 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 9 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Area under curve (time frame: 0.167, 0.333, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000 and 48.000 post-dose). 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 23 Dec 2014.