Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
Summary
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.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Infection
Intervention
Clarithromycin
Location
MDS Pharma Services
Phoenix
Arizona
United States
85044-5318
Status
Completed
Source
Roxane Laboratories
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00601315
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Clarithromycin
A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit protein synthesis in bacteria by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.
Eye Infections, Fungal
Infection by a variety of fungi, usually through four possible mechanisms: superficial infection producing conjunctivitis, keratitis, or lacrimal obstruction; extension of infection from neighboring structures - skin, paranasal sinuses, nasopharynx; direct introduction during surgery or accidental penetrating trauma; or via the blood or lymphatic routes in patients with underlying mycoses.
Mycobacterium Avium-intracellulare Infection
A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.
Pelvic Infection
Infection involving the tissues or organs in the PELVIS.
Zygomycosis
Infection in humans and animals caused by fungi in the class Zygomycetes. It includes MUCORMYCOSIS and entomophthoramycosis. The latter is a tropical infection of subcutaneous tissue or paranasal sinuses caused by fungi in the order Entomophthorales. Phycomycosis, closely related to zygomycosis, describes infection with members of Phycomycetes, an obsolete classification.
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Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection
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PubMed Articles
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Bioequivalence study of two oral formulations of clarithromycin in human male subjects.
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Rate of onset of inhibition of gut-wall and hepatic CYP3A by clarithromycin.
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Clinical Significance of Differentiation of Mycobacterium massiliense from Mycobacterium Abscessus.
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