Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Intervention: Clarithromycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Irving E Weston, MD, Principal Investigator, Affiliation: MDS Pharma Services
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.
Clinical Details
Official title: A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 500 mg Clarithromycin Tablets Under Fed Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
MDS Pharma Services, Phoenix, Arizona 85044-5318, United States
Additional Information
Starting date: March 2003
Ending date: March 2003
Last updated: February 5, 2008
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