Back to resultsBioequivalency Study of Clarithromycin Tablets Under Fed Conditions
Primary Purpose
Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clarithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Infection
Eligibility Criteria
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.
Sites / Locations
- MDS Pharma Services
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
NCT ID
NCT00602498
First Posted
September 20, 2007
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00602498
Brief Title
Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions
Official Title
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 500 mg Clarithromycin Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was the bioequivalence of a potential generic 500 mg clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin tablet, Biaxin® following a single 500 mg dose, administered with food.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two period, Seven day washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion Criteria:
Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irving E Weston, MD
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044-5318
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions
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