- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00774644
Bioequivalence Study of Clarithromycin 500mg Tablets Under 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 Fasting Conditions.
Study Overview
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 fasting conditions
Eligible subjects underwent pre-study examinations that included a physical examination, 12-lead ECG, and laboratory tests - including hematology, blood chemistries, urinalysis, infectious diseases (Hepatitis B, Hepatitis Ci HIV), and urine drugs of abuse. Laboratory testing for female subjects also included a serum pregnancy test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
St.Charles, Missouri, United States, 63301
- Gateway Medical Research Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 examination 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.
Clinical laboratory measurements will include the following:
- Hematology: hemoglobin, hematocrit,red blood cell count, platelets, and white blood cell count (with differential).
Exclusion Criteria:
- 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 the class of drug 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 and at check-in each study period. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
- Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
- Subjects who have taken any investigational drag within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
- Female subjects who are pregnant or who are able (women with child bearing potential).
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
clarithromycin 500 mg tablets of Ranbaxy Laboratories Limited
|
|
ACTIVE_COMPARATOR: 2
BIAXIN® 500 mg tablets containing clarithromycin 500mg tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Bioequiavlence
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B025511
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Clarithromycin 500mg
-
HK inno.N CorporationCompletedHealthyKorea, Republic of
-
CTI BioPharmaCovanceCompletedDrug Interaction StudyUnited States
-
Helwan UniversityCompleted
-
Onconic Therapeutics Inc.CompletedHelicobacter Pylori Associated Gastrointestinal DiseaseKorea, Republic of
-
Il-Yang Pharm. Co., Ltd.Severance HospitalCompletedDrug Interaction PotentiationKorea, Republic of
-
University of NottinghamUniversity of Oxford; Nottingham University Hospitals NHS Trust; University of... and other collaboratorsCompletedBacterial Infection Due to Helicobacter Pylori (H. Pylori) | Gastrointestinal Ulcer HaemorrhageUnited Kingdom
-
University Medical Center GroningenCompletedMultidrug-resistant Tuberculosis | Extensively Drug-resistant TuberculosisNetherlands
-
Ranbaxy Laboratories LimitedCompletedHealthyUnited States
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedAggressive Periodontitis, GeneralizedBrazil
-
Kirby InstituteUniversity of Medicine 2, Yangon, MyanmarCompletedHelicobacter Pylori InfectionMyanmar