Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
Recruiting in Palo Alto (17 mi)
MJ
Overseen byMark J Allison, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Roxane Laboratories
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.
Research Team
MJ
Mark J Allison, MD
Principal Investigator
MDS Pharma Services
Eligibility Criteria
Inclusion Criteria
No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Treatment Details
Interventions
- Clarithromycin (Macrolide Antibiotic)
Clarithromycin is already approved in Canada for the following indications:
Approved in Canada as Biaxin for:
- Acute maxillary sinusitis
- Acute otitis media
- Community-acquired pneumonia
- Uncomplicated skin and skin structure infections
- Helicobacter pylori eradication
- Mycobacterium avium complex (MAC) infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MDS Pharma ServicesPhoenix, AZ
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Who Is Running the Clinical Trial?
Roxane Laboratories
Lead Sponsor
Trials
102
Patients Recruited
5,600+