NCT00774696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2002

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

Enrollment Period

Same day

First QC Date

October 15, 2008

Last Update Submit

October 16, 2008

Conditions

Healthy

Keywords

Bioequivalence study of clarithromycin

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Clarithromycin 500 mg Tablets

Drug: clarithromycin 500mg tablets

2

ACTIVE COMPARATOR

BIAXIN® 500 mg tablets

Drug: clarithromycin 500mg tablets

Interventions

clarithromycin 500mg tabletsDRUG
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • g. Female subjects who are pregnant or who are able (women child bearing potential) to become pregnant during the study not be allowed to participate.
  • h. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gateway Medical Research Inc.

Saint Charles, Missouri, 63301, United States

Location

Related Links

MeSH Terms

Interventions

Clarithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 17, 2008

Study Start

December 1, 2002

Primary Completion

December 1, 2002

Study Completion

February 1, 2003

Last Updated

October 17, 2008

Record last verified: 2008-10

Locations

US(1)