HealthyNCT00774696
Bioequivalence Study of Clarithromycin 500 mg Tablets Under Non-Fasting Conditions
A study testing clarithromycin 500mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adult subjects under non-fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- clarithromycin 500mg tablets
- 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 siteUnited States
- Study dates
- Dec 2002to Feb 2003
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Source of Subjects: Non-institutionalized subjects consisting of members of the community at large.
- Characterization of Study Group
- All subjects selected for this study will be at least 18 years of age. Female subjects must be unable to become pregnant (postmenopausal for at least 1 year, or surgically sterile).
- Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examinati°n includes, but is not limited to, blood pressure, general observations, and history.
- Each female subject will be given a serum pregnancy test as part of the pre-study screening process. At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements. Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
- Drags of Abuse Screen: pre-study and at check-in each study period subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each Subject's case report forms.
Who cannot join
- Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
- Subjects who have a history of allergic responses to theclass of drag being tested (including any penicillin product) should be excluded from the study.
- All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures at check-in each study period. Subjects found to have urine concentrations of tested will not be allowed to participate.
- Subjects should not have donated blood or plasma for at least (30) days prior to first dosing of the study.
- Female subjects who are pregnant or who are able (women child bearing potential) to become pregnant during the study not be allowed to participate.
- All female subjects will be screened for pregnancy at check in each study period. Subjects with positive pr inconclusive results will be withdrawn from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway Medical Research Inc.
Saint Charles, Missouri, 63301
About this study
Official title: The Objective of This Study is to Compare the Relative Bioavailability of Clarithromycin 500 mg Tablets (Ranbaxy Laboratories Limited) With That of BIAXIN® 500 mg Tablets in Healthy, Adult Subjects Under Non-Fasting Conditions.
The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adult subjects under non-fasting conditions.
Read the detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioavailability study on clarithromycin formulations comparing clarithromycin 500mg tablets of Ranbaxy Laboratories with Biaxin® tablets 500mg (containing clarithromycin 500 mg)in healthy, adult, human, male subjects under fed conditions Subjects were given a standardized meal starting 30 minutes before their assigned dosing time consisting of one buttered English muffin, one fried egg, one slice of American cheese, one slice of Canadian bacon, 2.45 ounces of hash brown potatoes, six fluid ounces of orange juice, and eight fluid ounces of whole milk.
A single oral dose of clarithromycin 500mg was administered during each period under supervision of a trained Medical Officer.
During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and, clinical laboratory safety tests (hematology \& biochemical parameters) were performed again at the end of the study.
- Conditions
- Healthy
- Being tested
- clarithromycin 500mg tablets
- Keywords
- Bioequivalence study of clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin 500mg tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clarithromycin 500 mg Tablets Receives: Drug: clarithromycin 500mg tablets |
| 2 | Active comparator | BIAXIN® 500 mg tablets Receives: Drug: clarithromycin 500mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startDec 2002
- Primary completionDec 2002
- Study completionFeb 2003
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774696
- Sponsor's protocol ID
- B025512
- Status last verified
- Oct 2008
- First submitted
- 15 Oct 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Objective of This Study is to Compare the Relative Bioavailability of Clarithromycin 500 mg Tablets (Ranbaxy Laboratories Limited) With That of BIAXIN® 500 mg Tablets in Healthy, Adult Subjects Under Non-Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00774696
- Acronym / sponsor ID
- B025512
- Conditions
- Healthy
- Keywords
- Bioequivalence study of clarithromycin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 17 Oct 2008 (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.
The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adult subjects under non-fasting conditions.
Detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioavailability study on clarithromycin formulations comparing clarithromycin 500mg tablets of Ranbaxy Laboratories with Biaxin® tablets 500mg (containing clarithromycin 500 mg)in healthy, adult, human, male subjects under fed conditions Subjects were given a standardized meal starting 30 minutes before their assigned dosing time consisting of one buttered English muffin, one fried egg, one slice of American cheese, one slice of Canadian bacon, 2.45 ounces of hash brown potatoes, six fluid ounces of orange juice, and eight fluid ounces of whole milk.
A single oral dose of clarithromycin 500mg was administered during each period under supervision of a trained Medical Officer.
During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and, clinical laboratory safety tests (hematology \& biochemical parameters) were performed again at the end of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clarithromycin 500mg tabletsClarithromycin 500 mg Tablets |
| 2 | Active comparator | Drug: clarithromycin 500mg tabletsBIAXIN® 500 mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Source of Subjects: Non-institutionalized subjects consisting of members of the community at large.
- Characterization of Study Group
- Each female subject will be given a serum pregnancy test as part of the pre-study screening process. At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements. Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
- Drags of Abuse Screen: pre-study and at check-in each study period subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each Subject's case report forms.
Key exclusion criteria (7 listed)
- Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
- Subjects who have a history of allergic responses to theclass of drag being tested (including any penicillin product) should be excluded from the study.
- All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures at check-in each study period. Subjects found to have urine concentrations of tested will not be allowed to participate.
- Subjects should not have donated blood or plasma for at least (30) days prior to first dosing of the study.
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 |
|---|---|---|
| clarithromycin 500mg tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 17 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clarithromycin 500mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
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 6 inclusion and 7 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 17 Oct 2008. 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 United States. 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.
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?
Bioequivalence. 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 17 Oct 2008.