At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
Clarithromycin ER 500 mg tablets +1 moredrug
Likely dose
Clarithromycin ER 500 mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Extended Release Tablet Formulation of Clarithromycin (500 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Biaxin® XL Filmtab) in 22 Fed, Healthy, Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Clarithromycin ER 500 mg tablets and BIAXIN® XL 500 mg tablets for Healthy. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test population of 22 adult subjects under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2002
Primary CompletionAug 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 10, 2009
Enrollment StartAug 1, 2002
Primary CompletionAug 1, 2002
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Clarithromycin ER 500 mg tabletsdrug
1 x 500 mg
BIAXIN® XL 500 mg tabletsdrug
1 x 500 mg